Drug BD

Axodin - Fexofenadine Hydrochloride Tablet / Suspension

2014-11-04T23:25:00.001+06:00

Axodin^® is a preparation of Fexofenadine, a pharmacologically active metabolite of Terfenadine, is a non-sedating antihistamine with selective peripheral H₁ receptor antagonist activity. Axodin^® is indicated for the relief of symptoms associated with allergic rhinitis and allergic skin conditions e.g. chronic urticaria.

authentic non-sedative antihistamine

Does not impair performance and alertness of patients

Proves to be a reliable therapeutic choice in oculo-nasal allergies

Keeps patient free from troubling side effects during treatment.

Description:
Fexofenadine is a pharmacologically active metabolite of Terfenadine, is a non-sedating antihistamine with selective peripheral H1 receptor antagonist activity.
Fexofenadine Hydrochloride is rapidly absorbed into the body following oral administration, with Tmax occurring at approximately 1-3 hours post dose. The mean Cmax value was approximately 427 ng/ml and 494 ng/ml following the administration of a 120 mg and 180 mg dose (once daily) respectively.
Fexofenadine is 60-70% plasma protein bound.
Fexofenadine undergoes negligible metabolism, as it was the only major compound identified in urine and faeces of animal and man. The plasma concentration profiles of Fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11 to 16 hours after multiple dosing. The single and multiple dose pharmacokinetics of Fexofenadine are linear between 40 mg and 240 mg taken daily. The major route of elimination is believed to be via biliary excretion while upto 10% of ingested dose is excreted unchanged through the urine.

Indications:
Seasonal Allergic Rhinitis: Fexofenadine is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.
Chronic Idiopathic Urticaria: Fexofenadine is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.

Dosage and Administration:
For Tablet
Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria: Adults and Children 12 Years and older:
The recommended dose is 60 mg twice daily or 180 mg once daily with water. A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function.
Children 6 to 11 Years: The recommended dose is 30 mg twice daily with water. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function.

For oral Suspension:
Seasonal Allergic Rhinitis: Children 2 to 11 Years: The recommended dose of oral suspension is 30 mg twice daily. A dose of 30 mg (5 ml) once daily is recommended as the starting dose in pediatric patients with decreased renal function. Shake bottle well, before each use.

Chronic Idiopathic Urticaria: Children 6 months to 11years: The recommended dose of oral suspension is 30 mg (5 ml) twice daily for patients 2 to 11 years of age and 15 mg (2.5 ml) twice daily for patients 6 months to less than 2 years of age. For pediatric patients with decreased renal function, the recommended starting doses of oral suspension are 30 mg (5 ml) once daily for patients 2 to 11 years of age and 15 mg (2.5 ml) once daily for patients 6 months to less than 2 years of age. Shake bottle well, before each use.

Special Risk Groups:
Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of Fexofenadine Hydrochloride in these patients.

Contraindications:
The product is contraindicated in-patients with known hypersensitivity to any of its ingredients. Interaction with other medicaments and other forms of interaction: Fexofenadine does not undergo hepatic bio-transformation and is therefore unlikely to interact with drugs that rely upon hepatic metabolis. Fexofenadine Hydrochloride at doses of 120 mg twice daily has been safely co-administered with erythromycin (500 mg three times daily) and
ketoconazole (400 mg once daily) under steady state conditions in healthy volunteers. An increase in the level of Fexofenadine in plasma of 2 times was observed after co-administration of erythromycin or ketoconazole but this was not associated with any increase in adverse event or effects on the QT interval, compared to that seen when the drugs were given singly. Animal studies have shown that the increase in plasma level of Fexofenadine observed after co-administration of erythromycin or ketoconazole, appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary clearance or gastrointestinal secretion respectively.

Adverse Reactions:
In placebo-controlled trials, adverse events were comparable in Fexofenadine and placebo treated patients. Adverse events reported with Fexofenadine include:
Common: headache. Uncommon: fatigue, drowsiness, nausea, tachycardia, palpitations, dry mouth, nose and/or throat, dyspepsia and gastrointestinal disturbances (including diarrhea).
Rare: taste disturbances, anaphylactic/ anaphylactic reactions, dyspnea, chest tightness, increased hair loss/hair thinning, photosensitivity, dysmenorrhea, menstrual disorders. As with other non-sedating antihistamines, dizziness, nervousness, agitation, sleep disorders, insomnia or paroniria may infrequently be reported by patients. The incidence of such reports under Fexofenadine was similar to the incidence under placebo.
Effects on ability to drive and use machine
On the basis of the pharmacodynamic profile and reported adverse events it is unlikely that Fexofenadine Hydrochloride tablets will produce an effect on the ability to drive or use machines. In objective tests, Fexofenadine Hydrochloride has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration.
Fexofenadine did not cross the blood brain barrier in animal studies.

Overdose:
Most reports of Fexofenadine Hydrochloride overdose contain limited information. However, dizziness, drowsiness and dry mouth have been reported. Single doses upto 800 mg and doses upto 690 mg BID for 1 month or 240 mg QD for 1 year were studied in healthy subjects without the development of clinically significant adverse events as compared to placebo.

Use in Pregnancy and Lactation:
No evidence of teratogenicity was observed in animal reproduction studies when Terfenadine was given throughout organogenesis. No effects on female fertility or on prenatal or postnatal development were observed in terfenadine animal studies at non-maternally toxic doses. Data from supporting pharmacokinetic studies showing the extent of exposure to Fexofenadine (an active metabolite of terfenadine) in the terfenadine animal
studies demonstrate that they are relevant to the assessment of Fexofenadine Hydrochloride. However, the effects of fetal exposure at the higher doses of Fexofenadine tolerated in animals have not been examined. Fexofenadine should be used in pregnancy only if the potential benefit outweighs the potential risk to the fetus. There are no data on the content of human milk after administering Fexofenadine Hydrochloride. However, when
Terfenadine was administered to nursing mothers Fexofenadine was found to cross into human breast milk. Therefore Fexofenadine is not recommended for mothers breast feeding their babies.

Pharmaceutical Precautions:
Store in a cool & dry place, away from children.

Commercial Pack:
Axodin® 60 Tablet: Box containing 50 tablets in 5 x10's blister strips. Each tablet contains Fexofenadine Hydrochloride USP 60 mg.
Axodin® 120 Tablet: Box containing 30 tablets in 3 x 10's blister strips. Each tablet contains Fexofenadine Hydrochloride USP 120 mg.
Axodin® 180 Tablet: Box containing 30 tablets in 3 x 10's blister strips. Each tablet contains Fexofenadine Hydrochloride USP 180 mg.
Axodin® Suspension: Bottle containing 50 ml suspension. Each 5 ml contains FexofenadineHydrochloride USP 30 mg.

Source and Manufactured by

BEXIMCO PHARMACEUTICALS LTD.

TONGI, BANGLADESH BL 6893 280210

® Axodin is a registered trademark of Beximco Pharmaceuticals Ltd.

List of Essential Drugs

2014-11-04T00:35:00.001+06:00

Sl.	Name of drugs	Dosage form
1	Abacavir (ABC)	Oral Liquid, Tablet
2	Acetazolamide	Tablet
3	Acetylsalicylic acid	Suppository, Tablet
4	Aciclovir	Powder for injection, Tablet
5	Albendazole	Tablet (chewable)
6	Allopurinol	Tablet
7	Aluminium hydroxide + Magnesium hydroxide	Oral liquid, Tablet
8	Amitriptyline	Tablet
9	Amlodipine Besylate	Tablet
10	Amoxicillin	Capsule or Tablet, Powder for oral liquid, Powder for injection
11	Ampicillin	Powder for Injection
12	Anti-D immunoglobulin (human)	Injection
13	Antitetanus immunoglobulin (human)	Injection
14	Artemether + Lumefantrine*	Tablet
15	Artesunate	Injection, Tablet
16	Ascorbic Acid	Tablet
17	Atenolol	Tablet
18	Atropine	Injection, Solution (eye drops)
19	Barium Sulfate	Aqueous suspension
20	BCG vaccine	Injection
21	Benzathine benzylpenicillin	Powder for injection
22	Benzoic acid + Salicylic acid	Ointment or cream
23	Benzyl benzoate	Lotion
24	Benzyl penicillin	Powder for injection
25	Betamethasone	Ointment or cream
26	Bleomycin	Powder for injection
27	Bupivacaine	Injection
28	Calcium gluconate	Injection
29	Carbamazepine	Oral liquid, Tablet (chewable), Tablet (scored)
30	Charcoal, activated	Powder
31	Chlorambucil	Tablet
32	Chloramphenicol	Eye drops, Eye ointment
33	Chlorhexidine	Solution
34	Chloroquine	Oral liquid, Tablet
35	Chlorpheniramine	Injection , Tablet
36	Chlorpromazine	Injection, Oral liquid, Tablet
37	Ciprofloxacin	Tablet or powder for suspension
38	Cisplatin	Injection
39	Clofazimine	Capsule
40	Clotrimazole	Vaginal cream, Vaginal tablet
41	Cloxacillin	Capsule, Powder for injection, Power for oral liquid,
42	Condoms
43	Cyclophosphamide	Powder for injection, Tablet
44	Dapsone	Tablet
45	Dexamethasone	Injection
46	Dextran 70	Injectable solution
47	Diazepam	Injection, Tablet, Tablet (scored)
48	Didanosine (ddl)	Buffered powder for oral liquid, Capsule (unbuffered enteric coated), Tablet (buffered chewable, dispersible)

Si.	Name of drugs	Dosage form
49	Diethylcarbamazine	Tablet
50	Digoxin	Injection, Oral liquid, Tablet
51	Diloxanide	Tablet
52	Diphtheria antitoxin	Injection
53	Diptheria vaccine	Injection
54	Dopamine	Injection
55	Doxorubicin	Powder for injection
56	Doxycycline	Capsule or Tablet, Tablet (dispersible)
57	DPT vaccine	Oral + Injection
58	Efavirenz (EFV or EFZ)	Capsule, Oral liquid, Tablet
59	Enalapril	Tablet
60	Epinephrine (adrenaline)	Injection, Solution (eye drops)
61	Ergocalciferol	Capsule or Tablet, Oral liquid
62	Ergometrine	Injection
63	Erythromycin	Capsule or Tablet, Powder for injection, Powder for oral liquid
64	Ethambutol	Tablet
65	Ethinylestradiol + Levonorgestrel	Tablet
66	Ferrous salt	Oral liquid, Tablet
67	Ferrous salt + Folic acid	Capsule, Tablet
68	Fluconazole	Capsule, Oral liquid
69	Fluorescein	Eye drops
70	Fluorouracil	Injection, Ointment
71	Fluphenazine	Injection
72	Folic acid	Tablet
73	Furosemide	Injection, Tablet
74	Gentamycin	Injection, Solution (eye drops)
75	Gentamycin + Hydrocortisone	Ear drop
76	Glibenclamide	Tablet
77	Gliclazide	Tablet
78	Glucose	Injectable solution
79	Glucose with sodium chloride	Injectable solution
80	Glyceryl trinitrate	Tablet (sublingual)
81	Griseofulvin	Capsule or Tablet
82	Haloperidol	Injection, Tablet
83	Halothane	Inhalation
84	Heparin sodium	Injection
85	Hepatitis B vaccine	Injection
86	Homatropine	Solution (eye drops)
87	Human normal immunoglobulin	Intramuscular administration, Intravenous administration
88	Hydrochlorothiazide	Tablet (scored)
89	Hydrocortisone	Powder for injection, Ointment or cream, Suppository
90	Hyoscine butylbromide	Tablet, Injection
91	Ibuprofen	Tablet
92	Indinavir (IDV)	Capsule
93	Insulin Injection (Soluble)	Injection
94	Isoniazide	Tablet, Tablet (scored)
95	Isoniazide + Ethambutol	Tablet
96	Isosorbide dinitrate	Tablet (sublingual)
97	Ketamine	Injection
98	Lamivudine (3TC)	Oral liquid, Tablet,
99	Levamisole	Tablet
100	Levodopa + Carbidopa	Tablet

Si.	Name of drugs	Dosage form
101	Levothyroxine	Tablet
102	Lidocaine	Injection, Topical
103	Lithium Carbonate	Capsule or tablet
104	Lopinavir + Ritonavir (LPV/r)	Capsule, Oral liquid
105	Magnesium hydroxide	Oral liquid
106	Magnesium sulfate*	Injection
107	Mannitol	Injectable solution
108	Measles vaccine	Injection
109	Mebendazole	Tablet (chewable)
110	Mefloquine	Tablet
111	Mefformin	Tablet
112	Methotrexate	Powder for injection, Tablet
113	Methyldopa	Tablet : 250 mg
114	Methylrosanilinium chloride (gentian violet)	Aqueous solution, Tincture
115	Metoclopramide	Injection, Tablet
116	Metronidazole	Injection, Oral liquid, Suppository, Tablet
117	Miconazole	Ointment/Ceam
118	Miltefosine	Capsule/Oral liquid
119	Misoprostol	Tablet
120	Morphine	Injection, Oral liquid, Tablet, Tablet (prolonged release)
121	Naloxone	Injection
122	Nelfinavir (NFV)	Oral powder, Tablet
123	Neomycin Sulfate + Bacitracin	Ointment
124	Neostigmine	Injection, Tablet
125	Nevirapine (NVP)	Oral liquid, Tablet
126	Nicotinamide	Tablet
127	Nifedipine	Immediate release capsule
128	Nitrofurantoin	Tablet
129	Nitrous oxide	Inhalation
130	Nystatin	Oral Suspension
131	Omeprazole	Capsule
132	Oral rehydration salts	Powder
133	Oseltamivir	Tablet
134	Oxygen	Inhalation
135	Oxytocin	Injection
136	Paracetamol	Oral liquid, Suppository, Tablet
137	Paromomycin	Solution for intramuscular injection
138	Peritoneal Dialysis Solution	Intraperitoneal dialysis solution (of appropriate composition)
139	Permethrin	Cream, Lotion
140	Pertussis vaccine	Injection
141	Pethidine hydrochloride	Injection
142	Phenobarbital	Injection, Oral liquid, Tablet
143	Phenoxymethylpenicillin	Powder for oral liquid, Tablet,
144	Phenytoin	Capsule, Injection, Oral liquid, Tablet, Tablet (chewable)
145	Pilocarpine	Solution (eye drops)
146	Poliomyelitis vaccine	Oral
147	Polyvalent anti snake venom	Injection
148	Potassium chloride	Tablet, Solution
149	Povidone Iodine	Solution
150	Prednisolone	Tablet, Solution (eye drops)
151	Primaquine	Tablet
152	Procainamide	Injection
153	Procaine benzylpenicllin	Powder for injection

Si.	Name of drugs	Dosage form
154	Procarbazine	Capsule
155	Proguanil	Tablet
156	Promethazine	Oral liquid, Injection, Oral liquid, Tablet
157	Propranolol	Tablet
158	Protamine sulfate	Injection
159	Pyrazinamide	Tablet, Tablet (dispersible), Tablet (scored)
160	Pyridoxine	Tablet
161	Pyrimethamine	Tablet
162	Quinine	Injection, Tablet
163	Rabies immunoglobulin	Injection
164	Rabies vaccine	Injection
165	Retinol	Capsule, Tablet, Oral oily solution, Water-miscible injection
166	Riboflavin	Tablet
167	Rifampicin	Capsule or Tablet
168	Rifampicin + Isoniazid	Tablet
169	Rifampicin + Isoniazid + Ethambutol	Tablet
170	Rifampicin + Isoniazid + Pyrazinamide	Tablet
171	Rifampicin + Isoniazid + Pyrazinamide + Ethambutol	Tablet
172	Ritonavir	Oral liquid, Oral solid dosage form
173	Salbutamol	Injection, Oral liquid, Respirator solution for use in nebulizers, Tablet
174	Salicylic acid	Solution
175	Saquinavir (SQV)	Capsule
176	Senna	Tablet
177	Silver sulfadiazine	Cream
178	Sodium chloride	Injectable solution
179	Sodium Chloride 3%	IN fluid
180	Sodium Chloride quartet strength (0.225%) + Dextrose 5%	IN fluid
181	Sodium Hydrogen Carbonate	Injectable solution, Soution
182	Sodium stibogluconate	Injection
183	Sodium thiosulfate	Solution
184	Spironolactone	Tablet
185	Stavudine (d4t)	Capsule, Powder for oral liquid
186	Streptomycin	Powder for injection
187	Sulfadoxine + Pyrimethamine	Tablet
188	Sulfamethoxazole + Trimethoprim	Oral liquid, Tablet, Injection
189	Suxamethonium	Injection, Powder for injection
190	Tamoxifen	Tablet
191	Tenofovir disoproxil fumarate (TDF)	Tablet
192	Tetanus vaccine	Injection
193	Tetracycline	Eye ointment
194	Thiamine	Tablet
195	Thiopental	Powder for injection
196	Trimethoprim	Tablet
197	Tropicamide	Eye drops
198	Tuberculin, purified protein derivative (PPD)	Injection
199	Valproic acid	Oral liquid, Tablet (crushable), Tablet (enteric coated)
200	Vecuronium	Injection
201	Verapamil	Injection, Tablet
202	Vinblastine	Powder for injection
203	Vincristine	Powder for injection

Si.	Name of drugs	Dosage form
204	Vitamin B-Complex (Vitamin B1- 5 mg + Vitamin B2- 2 mg + Vitamin B6 - 2 mg + Nicotinamide 20 mg)	Tablet
205	Warfarin	Tablet
206	Water for Injection	Ampoule
207	Xylometazoline Hydrochloride	Nasal drops
208	Zidovudine (ZDV or AZT)	Capsule, Oral liquid, Solution for IV infusion injection, Tablet
209	Zinc sulphate	Oral liquid, Tablet

Atrizin - Cetirizine Hydrochloride Tablet, Syrup, Pediatric Drops

2014-11-04T00:14:00.001+06:00

Atrizin^®is an antihistamine preparation containing Cetitrizine Hydrochloride. Cetirizine is a piperazine derivative and potent functional antagonist of histamine H₁ receptors causing long acting antihistaminc action. Unlike conventional or 1st generation antihistamines, central sedation or antimuscarinic effects do not generally occur with the usual doses of Atrizin. Atirzin is a safe antihistamine for pediatric, young, elderly and even for pregnant women patients.Atrizin^®is indicarted for the prevention and symptomatic relief of allergic manifestations, such as seasonal allergic rhinitis, perennial allergic rhinitis, chronic idiopathic urticaria etc. Atrizin^®is the safe and trusted antihistamine for the family.

safe and trusted antihistamine for the family

Offers greater relief in SAR in children
Ensures treatment success in nasal congestion & rhinorrhea of children
Provide safety for the pregnant woman

Description:

Cetirizine is a piperazine derivative and a potent functional antagonist of histamine H1 receptors. Atrizin® is a long acting antihistamine. Central sedation or antimuscarinic effects do not generally occur with the usual doses of Atrizin®.

Indications:

Atrizin® is indicated for the prevention and symptomatic relief of allergic manifestations, such as:

- Seasonal allergic rhinitis

- Perennial allergic rhinitis

- Chronic idiopathic urticaria

Dosage and Administration:

Atrizin® tablet:

Adults and children over 12 years: 10 mg (1 tablet) once daily.

Atrizin® syrup: Adult & Children over 6 yrs: 10 mg (2 teaspoonful) daily.

Child 2-6 years: 5 mg (1 teaspoonful) daily or 2.5 mg (1/2 teaspoonful) twice daily.

Atrizin® Pediatric Drops:

Infants 6 months to 23 months: 2.5 mg (1 ml) as a single dose, if needed 5 mg (2 ml) in two divided doses;

2-5years: 5 mg (2 ml) as a single dose or 2.5 mg (1ml) twice a day.

6-11 years: 10 mg (4 ml) as a single or two divided by the physician.

The maximum recommended dose is 20 mg daily. Cetirizine is safe for use in the elderly patients. Less frequent dosing is advised in patients with reduced creatinine clearance.

Contraindication:

Cetirizine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to it or its parent compound - Hydroxyzine.

Adverse Reaction:

No potentially life threatening effects have been encountered.

Acute Overdose:

In the occasional cases patient taking a massive intentional overdose (150-300 mg), sedation has been the only adverse effect and complete recovery has ensured. Like other H1 receptor antagonists, Cetirizine has no specific antidote.

Precautions:

Neonates : The drug is not usually administered to neonates.

Children: Cetirizine is effective & well tolerated in children. No special precautions are required in children over 6 yrs of age.

Lactating mother: The extent of Cetirizine excretion in human breast milk is unknown but some animal studies have shown excretion in breast milk. Nursing mothers are advised not to take this medication.

Pregnant women: Cetirizine is not teratogenic in animals. Since the animal studies are not always predictive of human response, it should be used only if the potential benefit justifies the potential risk to the fetus.

Drug Interaction:

There are no reports of hazardous interactions with other drugs to date. Concomitant administration with alcohol or diazepam does not impair psychomotor performance any more than the impairment of performance produced by alcohol alone.

Commercial Pack:

Atrizin® Tablet: Box containing 15 blister strips of 10 film coated tablets, each tablet contains Cetirizine Hydrochloride BP 10 mg.

Atrizin® Syrup: Amber glass bottle containing 60 ml syrup. Each 5 ml syrup contains Cetirizine Hydrochloride BP 5 mg.

Atrizin® Pediatric Drops: Bottle containing 15 ml pediatric drops. Each ml contains Cetirizine Hydrochloride BP 2.5 mg.

source and Manufactured by

BEXIMCO PHARMACEUTICALS LTD.

TONGI, BANGLADESH BL 5310 290107

® Atrizin is a registered trademark of Beximco Pharmaceuticals Ltd.

Aerovil - Pheniramine Maleate Syrup

2014-11-03T23:42:00.000+06:00

Aerovil^®is a preparation of Pheniramine, which is a competitive H₁ histamine receptor antagonist.It is indicated in hay fever and perennial rhinitis, vasomotor rhinitis,mild uncomplicated allergic skin reactions like dermatitis, eczema, urticaria, angioedema,pruritis and vertigo.

® time tested antihistamine

§ Exhibits strong antihistamine activity

§ Guarantees confident relief from allergic symptoms

§ Cures rhinitis and make the life easier

§ Assures compliance for pediatric patients

Description:

Pheniramine is a competitive H₁ histamine receptor antagonist. Like other alkylamine antihistamines it is also antagonist of muscarinic cholinergic receptors and possesses local anesthetic properties. However, the concentration required for the latter effect is probably not achieved at therapeutic dose.

Indications:

Pheniramine is indicated in hay fever and perennial rhinitis, vasomotor rhinitis, mild uncomplicated allergic skin reactions like dermatitis, eczema, urticaria, angioedema and pruritis, and vertigo.lt has also been used for its antiemetic properties in the prevention and control of motion sickness.

Dosage and Administration:

Children:

Syrup is particularly preferable for children. 1-3 years : 1/2 a measuring spoonful (7.5 mg) 2-3 times daily.

4-12 years : 1 measuring spoonful (15 mg) 2-3 times daily.

Adult:

Adults and children over 12 years : 1-2 measuring spoonful (15-30 mg) 2-3 times daily.

Side Effects:

The most common side effect is sedation that varies from slight drowsiness to deep sleep. Inability to concentrate, lassitude, dizziness, muscular weakness and incoordination may also occur. Other side effects are headache, dry mouth, constipation, blurred vision, etc.

Precautions:

If drowsiness, patients should not drive or operate machinery requiring alertness. Alcohol and certain other CNS depressants can potentiate the sedative effects of antihistaminic and patient should be warned of these effects.

Contraindications:

Pheniramine is contraindicated with known hypersensitivity to pheniramine. New born and premature infants are also contraindicated as it may act as a CNS stimulant.

Use in Pregnancy and Lactation: Pheniramine is contraindicated in pregnancy since safety of pheniramine has not been thoroughly studied. The drug is not recommended during breast feeding, although the concentration achieved in the breast milk are unlikely to be of clinical significance.

Pharmaceutical Precautions:

Store in a cool, dry place, away from light. Keep out of reach of children.

Commercial Pack:

Aerovil® Syrup : Bottle containing 100 ml syrup. Each 5 ml contains Pheniramine Maleate BP15 mg.

Source and Manufactured by

BEXIMCOPHARMACEUTICALS LTD.

TONGI, BANGLADESH

® REGISTERED TRADEMARK

Envit-M Multivitamin with Mineral

2014-10-29T21:39:00.000+06:00

Description
Envit® -M is a balanced preparation of Vitamins and Minerals. All are in appropriate amounts, essential to replenish vitamin and mineral deficiencies and thus maintain proper growth and resistance of body against different diseases. Iron, Copper, Calcium, Manganese, Zinc that present in Envit® -M tablet act as co-factors for cell enzymes and thus help in normal metabolic functions.

Composition
Each Envit® -M tablet contains:

Vitamin A	BP	1.50 mg
Vitamin D	BP	10.00 mg
Vitamin C	BP/USP	64.00 mg
Vitamin E	BP	15.00 IU
Thiamine Mononitrate (Vit-B1)	BP	1.50 mg
Riboflavin (Vit. B2)	BP	1.70 mg
Nicotinamide	BP	20.00 mg
Pyridoxine Hydrochloride (Vit- B6)	BP	2.00 mg
Cyanocobalamin (Vit. B12)	BP	6.00 mg
Folic acid	BP	0.40 mg
Calcium Pantothenate	USP	10.92 mg
Ferrous Sulphate	BP	50.00 mg
Potassium Iodide	USP	196.00 mg
Potassium Sulphate	BP	11.14 mg
Magnesium Sulphate	BP	1.00 mg
Cupric Sulphate	BP	2.00 mg
Zinc Sulphate	BP	37.04 mg

Indication
Envit® -M is indicated for the treatment and/or prevention of Vitamin and Mineral deficiencies. Such as:

Conditions where absorption of Vitamins and Minerals become decreased, such as: Inadequate food intake due to restriction or imbalanced diet, which is always related to malnutrition and loss of appetite; gastric and intestinal dysfunction; long term alcoholism; chronic and acute infection; congestive heart failure; hyperthyroidism etc. are also the causes of inadequate absorption of vitamins.

Destruction of intestinal flora due to contraceptive pills, antibiotics and other drugs.

Special conditions relating deficiency of B Vitamins, Vitamin-C, A, D and minerals.

Conditions where requirement of Vitamin increases such as : Post operative condition, severe injury or burn, tissue destruction and wound, pregnancy, lactation, excessive bleeding during menstruation, growing children and for old ages.

To increase body resistance.

Dosage and Administration
1-2 tablets daily or as directed by the Physician.

Precaution
During the 1st trimester of pregnancy, larger dosage of Vitamin-A may cause teratogenesis, so this should be considered during prescribing Multivitamin. Again, excessive doses of Vitamin-A and D can lead to hypervitaminosis. Iron and Zinc chelate with Tetracyclines and absorption of all three agents may be impaired.

Side effect
Multivitamin with Mineral preparation with ordinany doses are usually nontoxic.

Contraindication
It is contraindicated to the patients with known hypersensitivity to any of its constituents.

How supplied
Envit® -M Tablet : Bottle contains 30 film coated tablets.

Manufacturer’s Source: IBN SINA

Doxysina - Doxycycline Capsule

2014-10-29T21:23:00.000+06:00

Description:
Doxysina® is a semisynthetic oxytetracycline derivative with bacteriostatic activities. It acts principally by interference with protein synthesis. Doxysina® is a broad spectrum antibiotic and is active against a wide range of gram-positive and gram-negative bacteria, spirochetes, chlamydia, mycoplasma, rickettsiae etc.

The drug is almost completely absorbed (96%) from gastro-intestinal tract. Food does not interfere with the absorption of Doxycycline. 90% of the drug in circulation is bound to plasma protein. The drug is excreted in the faeces, largely as an inactive conjugate or perhaps as a chelate.

Composition:
Each Doxysina® Capsule contains Doxycycline HCl, equivalent to Doxycycline BP 100 mg.

Indication:
Doxysina® has been used in the treatment of a large number of infections caused by susceptible organisms.

Respiratory tract infection : Pneumonia, influenza, pharyngitis, tonsillitis, bronchitis, sinusitis, otitis media and other streptococcal and staphylococcal infections where tetracycline resistance is not a problem.
Genitourinary tract infection : Pyelonephritis, cystitis, urethritis, gonorrhea, epididymitis, syphilis, chancroid and granuloma inguinale.
Chlamydial infection : Lymphogranuloma venereum, psittacosis, trachoma.
Intestinal diseases : Whipples disease, tropical sprue, blind loop syndrome. In acute intestinal amoebiasis Doxysina® may be a useful adjunct to amoebicide.
Bacillary infection : Brucellosis, tularaemia, cholera, traveller's diarrhoea.
Acne: Acne vulgaris, acne conglobata and other forms of acne.
Other infections : Actinomycosis, yaws relapsing fever, leptospirosis, typhus, rickettsial pox and Q fever, cellulitis, furunculosis, abscess and infections
caused by Mycobacterium marinum, Bordetella pertussis and Bacillus anthracis. Also given for prophylaxis of malaria.

Dosage and administration:
Adult : 200 mg at a time or 100 mg every 12 hours for the first day followed by 100 mg per day. The dosage may be doubled depending on severity of the infection.
Children (Over 8 years of age) : Patients weighed 100 pounds or less (<45 kg)2 mg/lb (4.4 mg/kg) divided into two doses on the first day of treatment; follow with 1 mg/lb (2.2 mg/kg) given as a single daily dose or divided into two doses on subsequent days. More severe infections : Upto 2 mg/lb (4.4 mg/kg) may be used. For children over 100 pounds (>45 kg) use the usual adult dose.
Doxycycline may be taken anytime of the day and in case of gastric irritation, may be taken with food or milk.
Special Dosage Schedule : Acute gonococcal infection : 200 mg immediately, then 100 mg at bed time on the first day, followed by 100 mg 2 times/day for 3 days.
Primary and secondary syphilis : 300 mg per day in divided doses for at least 10 days. Uncomplicated urethral, endocervical or rectal infections in adult caused by Chlamydia trachomatis : 100 mg twice daily for at least 7 days.
Acne : 50 mg daily for 6-12 weeks or longer.
Travelers' Diarrhoea : Doxycycline is used to prevent Traveler's diarrhoea caused by enterotoxigenic E. coli in a dose of 100 mg once a day for 3 weeks.

Precaution:
The use of drug of tetracycline group during tooth development (last half of pregnancy, infancy and childhood to the age of 12 years) may cause permanent discolouration of the teeth. Tetracyclines, therefore, should not be used in these age groups unless other drugs are not likely to be effective or are contraindicated.

Side effect:
Doxycycline may produce gastrointestinal irritation to a varying degree in some but not all individuals. Epigastric distress, abdominal discomfort, may occur. Long term therapy with doxycycline may produce hematological changes. Various skin reactions including rashes, urticaria, exfoliative dermatitis may follow the use of Doxycycline but they are rare.

Contraindication:
Hypersensitivity to any of the tetracyclines contraindicate the use of Doxycycline.

How supplied:
Doxysina® Capsule : Box contains 10x10's capsules in blister strip.

Manufacturer’s Source: IBN SINA

Dopadon® Domperidone-Gastrokinetics

2014-10-29T21:18:00.000+06:00

Description:
Dopadon®blocks the receptor binding activity of Dopamine. Though all of the Dopaminergic receptors (D1, D2, D3, D4& D5) are present in the brain but Dopadon®blocks only the chemoreceptor trigger zone and stomach. Dopadon®has an action to the gastrointestinal motility. Dopadon®does not readily enters the brain that’s the reason Dopadon®has insignificant effects (psychotropic and neurologic) on the dopaminergic receptors of Brain. Dopadon®accelerates transit through the small intestine, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Dopadon®increases lower esophageal spinchter pressure and esophageal peristalsis and prevents the regurgitation of gastric content, thus prevents the rumination.

Composition:

Dopadon®Tablet : Each Tablet contains Domperidone BP (as Domperidone Maleate BP) 10 mg.

Dopadon®Suspension : Each 5 ml suspension contains Domperidone BP 5 mg.

Indication:
1) Stimulation of Gastrointestinal mobility
a Esophageal reflux, Reflux esophagitis and gastritis
b. Diabetic gastroparesis.
c. Heartburn with or without regurgitations of gastric contents in the mouth.
d. Non-ulcer dyspepsia
e. Functional dyspepsia
f. Speeding barium transit in “follow-through” radiological studies.
g. Acute nausea and vomiting.

2) Prevention and Symptomatic relief of acute nausea and vomiting in adults from any cause but specifically:
a. Cytotoxic therapy
b. Nausea and Vomiting associated with L-dopa and bromocriptine treatment for parkinsonian patients.
c. Radiological therapy.

3) In treatment of migraine with paracetamol

Dosage and administration:
Adults : 1-2 Dopadon®Tablet (10 to 20 mg) or 10-20 ml Dopadon®Suspension every 4-8 hours daily.
Children : 0.2 - 0.4 ml Dopadon®Suspension/10 kg or 0.2 - 0.4 ml/Dopadon® Suspension per kg body weight every 4 - 8 hours daily.
Dopadon®Should be taken 15-30 minutes before meals.

Side effect:
Hyperprolactinemia may produce during the treatment with domperidone, which may result in galactorrhea, breast enlargement, soreness and reduced libido. Dry mouth, thirst, headache, nervousness, drowsiness, diarrhoea, skin rash and itching may occur. Extrapyramidal reactions are seen in patients in clinical studies.

Precaution:
Domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairement. There may be increased risk of extrapyramidal reactions in young children because of incompletely developed blood brain barrier.

Contraindication:
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in case of neonates. Domperidone should not be used whenever gastro-intestinal stimulation might be dangerous i.e; gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).

Use in pregnancy and lactation:
Pregnant Woman : Domperidone is not recomended in pregnancy. Lactating mother : Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantitiesinsufficient to be considered harmful.

Drug interaction:
Domperidone may reduce the hypoprolactinemic effect of bromocriptine. The action of domperidone on GI function may be antagonized by anti-muscarinics and opoid analgesics. Domperidone and MAO (monoamine oxidase) inhibitors combination treatment should be taken carefully.

How supplied:
Dopadon®Tablet : 10 x 10’s tablets in blister pack in a printed carton.
Dopadon®Suspension : Each bottle contains 60 ml suspension.

Manufacturer’s Source: IBN SINA

Dofixim® - Cefpodoxime proxetil USP - Antibacterial

2014-10-29T21:13:00.000+06:00

Description:
Cefpodoxime proxetil is an orally administered prodrug that is de-esterified in the intestinal wall to release cefpodoxime a broad spectrum, semisynthetic 3rd generation cephalosporin antibiotic. Like other -lactam antibiotics it is bactericidal and acts by inhibiting cell wall synthesis. It is more active than other oral cephalosporin against respiratory bacterial pathogens.

Composition:
Dofixim®Capsule : Each capsule contains Cefpodoxime proxetil USP equivalent to 100 mg Cefpodoxime.
Dofixim®Tablet : Each Tablet contains Cefpodoxime proxetil USP equivalent to 200 mg Cefpodoxime.
Dfixim®Dry Suspension : Each 5 ml reconstituted suspension contains Cefpodoxime proxetil USP equivalent to 40 mg Cefpodoxime.

Indication:

Upper respiratory tract infection : Acute otitis media, Acute maxillary sinusitis, Pharyngitis, Tonsilitis.
Lower respiratory tract infection : Acute community acquired pneumonia, acute bacterial exacerbation of chronic bronchitis.
Uncomplicated urinary tract infection : Cystitis, Pyuria. Skin and soft tissue infection : Furuncle, Cellulitis, Subcutaneous abscess, infectious atheroma.
Sexually transmitted disease : Acute uncomplicated urethral and cervical gonorrhoea.
Gastrointestinal Tract Infection : Typhoid fever

Drug interaction:

Antacids : Concomitant administration of high doses of antacids or H2- Blocker reduces peak plasma level by 24% to 42% and the extent of absorption by 27% to 30% respectively.

Probenecid : It inhibits the excretion of Cefpodoxime.
Nephrotoxic drugs : Close monitoring of renal function is advised when Cefpodoxime is administered concomitantly with compounds of known nephrotoxic potential.

Dosage and administration:
Dofixim®capsule should be administered only with food to enhance absorption but suspension may be given without regard to food.

Adults (Age 13 years and older)

Types of infection	Dosage	Duration
Upper respiratory tract infection including tonsillitis and pharyngitis.	100 mg	12 hourly for 5-10 days
Acute exacerbation of chronic bronchitis	200 mg	12 hourly for 10 days
Acute community acquired pneumonia	200 mg	12 hourly for 14 days
Uncomplicated gonorrhoea	200 mg	Single dose
Uncomplicated urinary tract infection	100 mg	12 hourly for 7 days
Skin and soft tissue infection	200-400 mg	12 hourly for 7-14 days
Acute maxillary sinusitis	200 mg	12 hourly for 10 days

Children (Age 15 days to 9 years)

Age of children	Dosage	Duration
15 days-6 months 6 months-2 years 3 years-8 years Over 9 years	4 mg/kg every 40 mg every 80 mg every 100 mg every	12 hours 12 hours 12 hours 12 hours

Side effects:
Dofixim®has very few side effects. Diarrhoea and rarely antibiotic associated with colitis, nausea, vomiting, abdominal discomfort etc. may occur. Other side effects include rashes, pruritus, urticaria, serum sickness, chest pain, myalgia, dyspepsia, dizziness, vertigo, fungal and vaginal infection.

Use in pregnancy and lactation:
There is no well-controlled and sufficient study of Cefpodoxime proxetil regarding its use in pregnancy. It was neither teratogenic nor embryocidal in animal trial. This drug should be given during pregnancy only if clearly needed. Because Cefpodoxime is excreted in human milk, a decision should be made whether to discontinue brest feeding or to discontinue the drug.

Contraindication:
Dofixim®is contraindicated in patient with known hypersensitivity to it or to other cephalosporin antibiotics.

How supplied:
Dofixim® Capsule : Box contains 2 X 4’s capsules in Alu-Alu Blister pack.
Dofixim® Tablet : Box contains 3 X 4’s capsules in Alu-Alu Blister pack.
Dofixim® Dry Suspension: Bottle contains dry powder for 50 ml & 100 ml suspension.

Manufacturer’s Source: IBN SINA

Diplor® Amlodipine besylate BP Film Coated Tablet

2014-10-29T20:59:00.001+06:00

Description:
Diplor® (Amlodipine) is a dihydropyridine calcium channel blocker, with a longer duration of action, used for the treatment of hypertension and angina pectoris. Administration of Diplor® (Amlodipine) results primarily in vasodilation, with reduced peripheral resistance, blood pressure and afterload, increased coronary blood flow and a reflex increase in heart rate. This in turn results in an increase in myocardial oxygen supply and cardiac output.

Composition:
Diplor® Tablet : Each tablet contains Amlodipine besylate BP equivalent to 5 mg Amlodipine.
Diplor®-10 Tablet : Each tablet contains Amlodipine besylate BP equivalent to 10 mg Amlodipine.

Indication:
1) Hypertension
2) Chronic stable angina
3) Vasospastic angina (Prinzmetal's or Variant angina)

Dosage and administration:

Hypertension : Usual dose is 5 mg once daily & maximum dose is 10 mg daily. Small, fragile elderly individuals, or patients with hepatic insufficiency may be started on 2.5 mg once daily. In the treatment of hypertension it may be used alone or in combination with other antihypertensive agents.

Angina Pectoris & Vasospastic Angina :The recommended dose is 5-10 mg daily, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patient will require 10 mg for adequate effect. Amlodipine may be used alone or in combination with other anti-anginal drugs.

Co-administration with other Antihypertensive or Antianginal drugs:Amlodipine has been safely administered with thiazides, ACE inhibitors, Beta Blockers, Long acting Nitrate or Sublingual Nitroglycerin.

Acute Over Dosage:
In humans, experience with over dosage of Amlodipine is limited. If massive over dosage occurs, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential.

Side effect:
The most common side effects are dizziness, flushing, headache, hypotension and peripheral oedema, gastrointestinal disturbance, increased the frequency of micturation, lethargy and eye pain may occur. A paradoxical increase in ischemic chest pain may occur at the start of the treatment.

Caution:
Caution should be taken in patients with hepatic impairment, congestive heart failure, sinus node disease, aortic stenosis, beta-blocker withdrawal, during pregnancy and breast-feeding.

Contraindication:
Amlodipine is contra-indicated in patients with known hypersensitivity to dihydropyridine derivatives.

Storage Instruction:
Store the tablets in a dry place, at 15° - 30°C, away from light. Keep all the medicines away from the reach of children.

How supplied:
Diplor® Tablet : Each box contains 3 x 10's Tablets in Blister Pack.
Diplor®-10 Tablet : Each box contains 3 x 10's Tablets in Blister Pack.

Manufacturer’s Source: IBN SINA

Darmacort® Clobetasol Propionate USP 0.05% w/w Cream/Ointment

2014-10-29T20:53:00.000+06:00

Description:
Clobetasol Propionate is a corticosteroid used typically for it's glucocorticoid activity in the treatment of various skin dieseases. It has potent anti-inflammatory and immunosuppressive effects.

Composition:
Dermacort®Cream/Ointment : White nonstaining water miscible cream
/Ointment containg Clobetasol Propionate USP 0.05% w/w.

Indication:
Dermacort®Cream/Ointment is indicated in:
* Initial control of all forms of hyperacute eczema.
* Chronic hyperkeratotic psoriasis of any of the body.
* Chronic hyperkeratotic eczema of the hands and feet.
* Hypertrophic lichen planus.
* Severe acute photosensitivity.
* Pretibial myxoderma.
* Suppression of reaction after cryotherapy.

Dose & Administration
Apply Dermacort® Cream/Ointment sparingly to the affected areas once or twice daily until improvement occurs. As with other highly active topical steroid preparation, therapy should be discontinued when control is achieved. If a longer course is necessary, it is recommended that treatment should not be continued for more than four weeks without the patient's condition being observed. Repeated short courses of Dermacort®may be used to control exacerbation. In very resistant lesions especially where there is hyperkeratosis, the anti-inflammatory effect of Dermacort®can be enhanced by occluding the treatment area with polythene film. Only overnight occlusion is usually abequate to bring about a satisfactory response, Thereafter, improvement can usually be maintained by application without occlusion.

Contraindication:
It is contraindicated in:
* Cutaneous infections such as impetigo, tinea corporis and herpes simplex.
* Infestation such as scabies.
* Neonates (children less than one year old.)
* Acne vulgaris.* Rosacea
* Gravitational ulceration

Precaution:

Long-term continuous use of Clobetasol cream/ointment should be avoided, particularly in infants and children, in whom adrenal suppression occurs readily.
If required for use in children, it is recommended that the treatment should be reviewed weekly. The face more than other area of the body may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating facial conditions. If applied to the eyelid, care is needed to ensure that the preparation doesn't enter the eye, as glaucoma may result. Appropriate microbial therapy should be used whenever treating inflammatory lesions, which have been infected. Any spread of infections require withdrawal of corticosteroid therapy and institution of suitable systemic chemotherapy.
Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.

Use in pregnancy & lactation:
Topical administration of corticosteroids to the pregnant animals can cause abnormalities of fetal development. The relevance of this finding to human being has not been established. However, topical steroids shouldn't be used extensively in pregnancy, i.e. in large amount or for prolonged period.

Side-effect:
Provided the weekly dosage is less than 50 gm in adult, any pituitary adrenal suppression is likely to be transient with a rapid return to normal values, once the short course of steroid therapy has ceased. Prolonged and intensive treatment with a highly active corticosteroid preparation may cause atrophic changes, such as thinning, striae and dilatation of the superficial blood vessels, particularly when occlusive dressings are used or where skin folds are involved. Clobetasol cream/ointment is usually well tolerated but if signs of hypersensitivity appear, application should be stopped immediately.

How supplied:
Dermacort®Cream/Ointment : Tube contains 10 gm cream/ointment.

Manufacturer’s Source: IBN SINA

Cefixim Cefixime-Antibiotic

2014-10-29T20:43:00.001+06:00

Description:
Cefixim®is a broad spectrum, third generation oral Cephalosporin antibiotic for oral use. It is a bactericidal and is stable to hydrolysis by beta-lactamases. The drug kills bacteria by interfering with the synthesis of bacterial cell wall. It is highly effective against most Enterobacteriaceae, Haemophilus influenzae, Neisseria gonorrhoeae, -haemolytic Streptococcus and Streptococcus pneumoniae.
About 65% of the drug in thecirculation is bound to plasma protein. Cefixim® is mainly excreted unchanged in bile and urine.

Composition:
Cefixim®Capsule : Each capsule contains Cefixime trihydrate USP, equivalent to Cefixime USP 200 mg.
Cefixim®Dry Suspension : Each 5 ml suspension (reconstituted from Dry Syrup) contains Cefixime trihydrate USP, equivalent to Cefixime USP 100 mg.

Indication:
Cefixim®is indicated in the treatment of following acute infections caused by susceptible microorganisms:
Upper respiratory tract infection (URTI) : Otitis media and others where causative organisms are known or suspected to be resistant to other commonly used antibiotics or where treatment failure may carry significant risk.
Lower respiratory tract infection (LRTI) : Bronchitis.
Gastrointestinal tract infection (GITI) : Typhoid fever.
Urinary tract infection (UTI): Cystitis, cystourethritis, pyelonephritis.

Dosage and administration :

With Cefixim®the usual course of treatment is 7 days. This may be continued up to 14 days.
Adults & Children over 10 years old: The recommended adult dosage is 1-2 capsule (200-400 mg) daily according to the severity of infection, given in either as a single dose or in two divided doses.
Elderly: Elderly patients may be given the same dose as recommended for the adults. Renal functions should be assessed and dosage should be adjusted in severe renal impairment.
Children : The recommended dosage for children is 8 mg/kg/day administered as single dose or in two divided dose.

As a general guide the following daily doses are suggested:
Cefixim®
Children (6-12 months) : Suspension 3.75 ml (75 mg) daily.
Children (1-4 years) : Suspension 5 ml (100 mg) daily.
Children (5-10 years) : Suspension 10 ml (200 mg) daily.
Children weighing more than 50 kg or older than 10 years : Adult dose of Cefixim®(200-400 mg daily) is recommended.

Pecaution:
In presence of impaired renal function Cefixim®should be administered with caution. In patient creatinine clearance less than 20 ml/min, it is recommended that a dose of 200 mg once daily should not be exceeded.

Use in Pregnancy and Lactation:
Cefixim®should not be used in pregnancy or nursing mother unless considered essential by the physician.

Side effect:
Cefixim®is generally well tolerated. The majority of adverse reactions observed are mild and self-limiting in nature. GIT disturbances : Diarrhoea and changes in stool colour, nausea, abdominal pain, dyspepsia, vomiting and flatulence. CNS disturbances: Headache and dizziness. Hypersensitivity reactions: Rash, pruritus, urticaria, drug fever and arthralgia have been observed.

Contraindication:
Cefixim®is contraindicated in patients with known hypersensitivity to Cephalosporin group of drugs.

How supplied:
Cefixim® Capsule : Box contains 1 x 5’s capsules in blister pack.
Cefixim® Dry Suspension : Bottle contains dry powder for 50 ml suspension.

Manufacturer’s Source: IBN SINA

Bromotex - Bromhexine Hydrochloride

2014-10-29T20:36:00.000+06:00

Description:
Bromotex® (Bromhexine HCl) is highly effective mucolytic expectorant.

Composition:
Bromotex® Syrup: Each 5 ml Syrup contains Bromohexine Hydrochloride BP 4 mg.

Indication:
Bromotex® (Bromhexine HCl) is indicated in the treatment of respiratory disorders associated with productive cough. These include; tracheobronchitis, bronchitic with emphysema, bronchiectasis, bronchitis with bronchospasm, chronic inflammatory pulmonary conditions and pneumoconiosis.

Dosage and administration:
Bromotex® Syrup:
Adults: The recommended daily dose is 2 to 4 teaspoonful 3 tines daily. Initially 4 teaspoonful 3 times daily and then as required.
Children: Suggested dosage for children under 2 years is ¼ teaspoonful 3 times daily, for 2-5 years ½ teaspoonful 3 times daily and for children aged 5-10 years 1 teaspoonful 3 times daily.

Precaution:
Mucolytics may disrupt the gastric mucosa so bromhexine should be used with care in patients with a history of peptic ulceration. Care is also advisable in asthmatic patients.

Contraindication:
Bromhexine is contraindicated for use in patients with known hypersensitivity to bromhexine hydrochloride (or any of the other ingredients in the product).

Side effect:
Gastrointestinal side effects may occur occasionally with Bromhexine and a transient rise in serum aminotransferase values has been reported. Other reported adverse effects include headache, dizziness, sweating and skin rash.

Use in pregnancy and lactation:
Category B: Bromhexine has been taken by a large number of pregnant women and women of child bearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
It is not known whether Bromhexine is excreted in breast milk or whether it has a harmful effect on the breastfeeding infant. Therefore it is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.

Storage:
Store at a cool and dry place. Protect from light.

How supplied:
Bromotex® Syrup: Each PET bottle contains 100 ml syrup and a plastic spoon.

Manufacturer’s Source: IBN SINA

Bactin - Ciprofloxacin 0.3% - Sterile Eye Drops & Ointment

2014-10-29T20:29:00.000+06:00

Description:
Bactin® Eye Drops is 0.3% isotonic sterile aqueous ophthalmic solution of Ciprofloxacin. Bactin® Eye Ointment is 0.3% ophthalmic sterile ointment of Ciprofloxacin. Ciprofloxacin is a broad spectrum fluoroquinolone antibacterial, having bacteriocidal activity against a wide range of Gram positive and Gram negative pathogenic bacteria. Ciprofloxacin achieves therapeutic level in various ocular tissues and fluids, hence topical administration of this drug is useful in the treatment of various ocular infections.

Composition:
Bactin® Eye Drops : Each ml contains Ciprofloxacin USP 3 mg.
Bactin® Eye Ointment : Each gm contains Ciprofloxacin USP 3 mg.

Indication:
Bactin® Eye Drops or Ointment is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Corneal Ulcer : Pseudomonas aeruginosa, Streptococcus viridans (Drops only), Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Serratia marcescens.
Cojunctivitis : Staphylococcus aureus, Staphylococcus epidermidis, Streptoccoccus pneumoniae. H. influenzae
Also, Bactin Eye Drops is indicated for prevention of ocular infections after removal of corneal or conjunctival foreign body, after damage from chemical or physical agents, before and after surgery.

Dosage and Administration:
Corneal ulcer : Bactin® Eye Drops: 1st day : Two drops into the affected eye every 15 minutes for the first 6 hours and then 2 drops into the affected eye every 30 minutes for the remainder of the 1st day.
2nd day : Instill 2 drops in the affected eye hourly. 3rd day : On the 3rd through the 14th day, instill 2 drops in the affected eye every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis: Bactin® Eye Drops: 1 or 2 drops instilled into the conjunctival sac(s) every 2 hours while awake for 2 days and 1 or 2 drops every 4 hours while awake for the next 5 days.
Bactin® Eye Ointment: Apply a 1/2" ribbon into the conjunctival sac 3 times daily on the first two days, then apply a 1/2" ribbon two times a day for the next 5 days.

Precaution:
If irritation persists or increases, discontinue the use and consult with the physician. Don't touch the dropper tip to any surface since this may contaminate the solution. Use this solution within 1 month after opening the container. A white crystalline precipitate may be observed in the superficial portion of the corneal defect in patients of bacterial corneal ulcer. But the precipitate will not preclude continued use of Ciprofloxacin, nor will it adversely affect the clinical course of the ulcer or visual outcome.

Pregnancy and Nursing mother:
Safety in pregnancy & lactating mother have not been established. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Bactin solution is administered to a nursing mother.

Paediatric Use:
Safety & effectiveness in children below the age of 1 year (drops) / 2 year (Ointment) have not been established.

Side effect:
The most frequently reported drug related adverse reaction was local burning or discomfort. Other reactions are lid margin crusting, crystals/ scales, foreign body sensation, itching, conjunctival hyperemia, corneal staining, keratopathy/keratitis, allergic reaction, lid edema, tearing, photophobia, nausea and decreased vision.

Contraindication:
Bactin Eye Drops/Ointment is contraindicated in patients with known hypersensitivity to any of its components.

How supplied:
Bactin® Eye Drops : Plastic dropper bottle contains 5ml or 10 ml drops.
Bactin® Eye ointment : Tube contains 3 gm ointment.

Manufacturer’s Source: IBN SINA

Bactin - Ciprofloxacin-Antibacterial Film Coated Tablet

2014-10-29T14:37:00.002+06:00

Description:
Bactin® is a film coated tablet which is a broad spectrum synthetic Quinolone antiinfective agent. It is active against most of the gram negative aerobic bacteria like Enterobacteriaceae & Pseudomonas aeruginosa and gram positive aerobic bacteria including penicillinase producing, penicillinase nonproducing and Methicillin-resistant Staphylococci. The bactericidal action of Ciprofloxacin results from interfering with the enzyme DNA gyrase.

Composition:
Bactin®Tablet : Each tablet contains Ciprofloxacin USP 250 mg.
Bactin® 500 Tablet : Each tablet contains Ciprofloxacin USP 500 mg.
Bactin® 750 Tablet : Each tablet contains Ciprofloxacin USP 750 mg.

Indication:
Bactin®is indicated for the management of single or mixed infections caused by two or more susceptible microorganisms. It can also be used against infections caused by organisms resistant to other antibiotics. Bactin®is indicated for the treatment of the following infections.
Gastrointestinal tract infection : Enteric fever and infected diarrhoea.
Respiratory tract infection : Pneumonia, acute and chronic bronchitis, cystic fibrosis, bronchiectasis and empyema.
Urinary tract infection : Complicated and uncomplicated urethritis, cystitis, pyelonephritis, prostatitis and epididymitis.
Severe systemic infection : Septicemia, bacteremia, infection in
immunosuppressive patient with hematological or solid tumors.
Skin and soft tissue infection : Wound infection, abscess, infected ulcer, cellulitis, infected burn, erysipelas and otitis externa.
Biliary tract infection : Cholangitis, cholecystitis, empyema of the gall bladder.

Bone and joint infection : Osteomyelitis and arthritis.
Eye, ear, nose and throat infection : Otitis media, sinusitis, mastoiditis and tonsillitis.
Pelvic infection : Salpingitis, endometritis and pelvic inflammatory diseases.
Abdominal infection : Peritonitis & intra-abdominal abscess.
Gonorrhoea : Urethral, rectal and pharyngeal gonorrhoea caused by beta-lactamase producing organisms or organisms moderately sensitive to penicillin.

Dosage and administration:
Adult : The usual adult dose is 250-750 mg twelve hourly.
Adolescent and Children : Generally not recommended but where the benefit is more than potential risk, the dose should be 7.5-15 mg/kg/day depending upon the severity of infection, administered in two divided doses.

Dosage Schedule:

Infection	Dose	Duration
1. Enteric Fever	500 mg	12 hourly 7 -14 days
2. Infected Diarrhoea	500 mg	12 hourly 5 -7 days
3. Chronic Salmonella carriers	500 - 750 mg	12 hourly 28 days
4. Complicated UTI	500 mg	12 hourly 5-7 days
5. Uncomplicated UTI	250 mg	12 hourly 3 -5 days
6. Respiratory Tract Infection	500 - 750 mg	12 hourly 7 -14 days
7. Skin & Soft Tissue Infection	500 - 750 mg	12 hourly 7 -14 days
8. Uncomplicated Gonorrhoea	250 mg	Single dose.
9. Wound Infection	250 mg	12 hourly 7 -14 days
10. Bone & Joint Infection	500 - 750 mg	12 hourly 7 -14 days but may need to continue for 4-6 weeks or longer.
11. Other Infections	500 - 750 mg	12 hourly 7 -14 days

Side effect:
Gastrointestinal disturbances like nausea, vomiting, diarrhoea, dyspepsia and abdominal pain; Disturbances of the CNS eg. dizziness, drowsiness, headache, tiredness, confusion, convulsion, skin rashes, pruritus and possible systemic reactions may occur. It has also been reported that joint pain, mild photosensitivity may occur and liver enzyme, serum bilirubin, creatinine levels may increase slightly.

Contraindication:

Ciprofloxacin is contraindicated in patients with a history of hypersensitivity to it any of its components and to other Quinolones.

Precaution:
Ciprofloxacin should be used with great caution in patient with a known history of epilepsy or other factors which predispose to seizure and convulsion. Patients should be advised to take Ciprofloxacin two hours after meal. Patients should be advised not to take Antacid containing aluminium or magnesium

Bactin® concomitantly or within two hours after dosing and also requested to drink plenty of water.

Pregnancy and lactation:
Ciprofloxacin has been shown to cause arthropathy in immature animals and therefore its use during pregnancy is not yet recommended. It has been reported that Ciprofloxacin is secreted in milk during administration to nursing mother and is thus not recommended yet.

Children & growing adolescents:
The use of quinolones can be considered if it is felt to be necessary by a registered physician, with no suitable alternatives, for a particular clinical situation.

Drug interaction:
Concurrent administration of Ciprofloxacin with theophylline and caffeine may potentiate the adverse effects of theophyline and caffeine. Antacid containing aluminium or magnesium may decrease the bioavailabiltiy of Ciprofloxacin. Quinolones, including Ciprofloxacin, have been reported to enhance the effects of the oral anticoagulantl ike Warfarin or its derivatives.

How supplied:
Bactin®Tablet : Box contains 2 x 10's film coated tablets in blister pack.
Bactin®500 Tablet : Box contains 2 x 10's film coated tablets in blister pack.
Bactin®750 Tablet : Box contains 2 x 10's film coated tablets in blister pack.

Manufacturer’s Source: IBN SINA

Axosin- Ceftriaxone Sodium USP - IV / IM Injection

2014-10-29T14:30:00.000+06:00

Description:
Axosin® - (Ceftriaxone) is a board spectrum parenteral third generation cephalosporin antibiotic. The drug is highly resistant to bacterial b-lactamases and has a good activity against many gram-positive and gram-negative areobic and some anaerobic bacteria. It inhibits bacterial cellwall synthesis in a manner similar to that of penicillin. Once a day dose for many infections is an advantage for this drug.

Composition:
Axosin® 250 mg IM and IV: Each vial contains Ceftriaxone 250 mg as sterile Ceftriaxone Sodium USP.
Axosin® 250 mg IM and IV: Each vial contains Ceftriaxone 500 mg as sterile Ceftriaxone Sodium USP.
Axosin® 1 gm IM and IV : Each vial contains Ceftriaxone 1 gm as sterile Ceftriaxone Sodium USP.

Indication:
Axosin® (Ceftriaxone) is indicated for the treatment of the following major infections when caused by susceptible ororganisms:

1. Renal & urinary tract infection
2. Lower respiratory tract infection particularly pneumonia
3. Gonococcal infection
4. Skin, soft tissue, bone & joint infection
5. Bacterial meningitis
6. Serious bacterial infection e.g. septicemia
7. ENT infection
8. Infection in cancer patients
9. Prevention of postoperative infection
10. Pre-operative prophylaxis of infection associated with surgery
11. Typhoid fever.

Dosage and Administration:
Adult : It is usually given to adults in a dose of 1 to 2 gm daily as a single dose or in two divided doses depending on the type and severity of infection. In severe infection up to 4 gm daily may be given. A single intramuscular dose of 250 mg is recommended for the treatment of uncomplicated gonorrhoea in adult. For surgical prophylaxis in adults, single dose of 1 gm may be administered 0.5 to 2 hours prior to surgery.

Children : Suggested doses for infants and children are 50 to 75 mg per kg body weight once a day; for servere infection up to 80 mg per kg body weight daily may be given.

Neonates : The maximum dose should not exceed 50 mg per kg; intravenous doses in neonates should be given over 60 minutes. Duration of Therapy: The duration of therapy varies according to the course of the diseases be continued for a minimum of 48-72 hours after the patients has become a febrile or evidence of bacterial eradication has been obtained.

Side effect:
Well tolerated, side effects are relatively infrequent, usually mild and transient. The most common side effects are gastro-intestinal consisting mainly of loose stool, diarrhoea, nausea, vomiting stomatitis and glossitis.

Contra-indication:
Ceftriaxone sodium should not given in patients with a history of hypersensitivity to cephalosporin antibiotics. It is contraindicated in premature infants and in fullterm infants during the first 6 weeks of life.

Pharmaceutical Precautions:
Storage:
The recommended maximum Storage temperature for Axosin® vials is 25 °C. Reconstituted solutions are stable for 6 hours at room temp in daylight, and for 24 hours at 5 °C.

How supplied:
Axosin® Supplied in a combipack as follows.
Axosin® 250 mg IM Injection : 1 vial of 250 mg Ceftriaxone Injection and one ampoule of 2 ml 1% Lidocaine USP injection.
Axosin® 500 mg IM Injection : 1 vial of 500 mg Ceftriaxone Injection and one ampoule of 2 ml 1% Lidocaine USP injection.
Axosin® 1 gm IM Injection : 1 vial of 1gm Ceftriaxone Injection and one ampoule of 3.5 ml 1% Lidocaine USP injection.
Axosin® 250 mg IV Injection : 1 vial of 250 mg Ceftriaxone Injection and one ampoule of 5 ml water for injection BP.
Axosin® 500 mg IV Injection : 1 vial of 500 mg Ceftriaxone Injection and one ampoule of 5 ml water for injection BP.
Axosin® 1 gm IV Injection : 1 vial of 1gm Ceftriaxone Injection and one ampoule of 10 ml water for injection BP.

Manufacturer’s Source: IBN SINA

Antanil - Aluminium Hydroxide & Magnesium Hydroxide

2014-10-29T13:37:00.000+06:00

Description:
Antanil® is a non systemic antacid preparation capable of neutralizing the excess acid and healing up the ulcers.

Composition:
Antanil® Tablet : Each tablet contains Aluminium Hydroxide BP 250 mg and Magnesium Hydroxide BP 400 mg.
Antanil® Suspension: Each 5 ml contains Aluminium Hydroxide Gel BP equivalent to Aluminium hydroxide BP 200 mg and Magnesium Hydroxide BP 400 mg.

Indication:
o Hyperacidity
o Gastritis, heart burn and dyspepsia.
o Peptic ulcer, gastric ulcer, duodenal ulcer.

Dosage and Administration:
Tablet : After meal, 2 tablets 3-4 times daily by chewing or as advised by the physician.
Suspension : After meal, 2 teaspoonful Antanil suspension 3-4 times daily or as advised by the physician.

Side effect:
Antanil® has little or no side effect. Diarrhoea or constipation may occur occasionally.

Precaution:
Antacid containing Aluminium Hydroxide should not be taken concomitanty with any form of Tetracycline & Digoxin as the absorption of latter may be affected.

Contraindication:
Antacid should not be used if the patient has the deficiency of phosphate and in case of patient with kidney failure.

How supplied:
Antanil® Tablet : Box contains 10 x 20's chewing tablets in blister strip
Antanil® Suspension : Bottle contains 200 ml of suspension.

Manufacturer’s Source: IBN SINA

Antanil Plus - Aluminium Hydroxide, Magnesium Hydroxide and Simethicone

2014-10-29T13:27:00.001+06:00

Description:
Antanil® Plus is a non systemic antacid and antiflatulent preparation. When ingested, Antanil® Plus neutralizes gastric acid and forms neutral salts within the stomach. Aluminium hydroxide can cause constipation and magnesium hydroxide has a laxative effect. Aluminium and magnesium combined to offset their individual effects on bowel function. Simethicone is included to limited bloating and gas.

Composition:
Antanil® Plus Tablet : Each tablet contains Aluminium Hydroxide Dried Gel BP 400 mg. Magnesium Hydroxide BP 400 mg and Simethicone USP 30 mg.
Antanil® Plus Suspension : Each 5 ml contains Aluminium Hydroxide Compressed Gel BP, equivalent to Aluminium Oxide 200 mg, Magnesium Hydroxide BP 400 mg and Simethicone USP 30 mg.

Indication:
Antanil® Plus is used to treat an upset stomach caused by heartburn, acid indigestion, or sour stomach; to treat peptic ulcer, hiatal hernia or other conditions caused by hyperacidity and to prevent ulcer or bleeding from ulcer. It is also indicated to expel excess gas from the intestine.

Dosage and Administration:
Antanil® Plus Tablet: 1-2 tablets to be chewed half to 1 hour after or in between meals and at bed time or as required.
Antanil® Plus Suspension: 2-3 teaspoonful half to 1 hour after or in between meals and at bed time or as required.
To be effective, chewable Antanil® Plus tablet must be chewed thoroughly before swallowing followed by a full glass of water. Shake suspension well before pouring each dose.

Side effect:
Antanil® Plus can cause nausea, loss of appetite, constipation or diarrhoea, weakness, or headache.

Precaution:
Caution has to be taken in patients with kidney problem. Symptoms of overdose may include dizziness, fatigue, weakness, nausea, vomiting, loss of appetite, drowsiness, slow or shallow breathing, or loss of consciousness.

Contraindication:
Antanil® Plus is contraindicated especially to Tetracycline, Ferrous Sulfate (iron), drugs used for arthritis (e.g., Aspirin, Indomethacin); Digoxin, Isoniazid, Pseudoephedrine, Diazepam, Methenamine, Ketoconazole.

How supplied:
Antanil® Plus Tablet : Box contains 10 x 10's chewable tablets in blister strip.
Antanil® Plus Suspension : Bottle contains 200 ml suspension.

Manufacturer’s Source: IBN SINA

Anosea - Meclizine Hydrochloride

2014-10-29T13:18:00.000+06:00

Description:
Meclizine Hydrochloride is a first generation piperazine-derivative antihistamine, that shows marked protective activity against nebulized histamine and used as an antiemetic.

Pharmacology:

Anosea (Meclizine Hydrochloride) has antiemetic, anticholinergic and antihistaminic properties. It reduces the sensitivity of the labyrinthine apparatus. The action may be mediated through nerve pathways to the vomiting center (VC) from the chemoreceptor trigger zone (CTZ), peripheral nerve pathways, the VC, or other CNS centers.

Anosea (Meclizine Hydrochloride) has an onset of action of 30 to 60 minutes and duration of action is 12 to 24 hours.

Composition:

Each film-coated tablet contains Meclizine Hydrochloride USP 50 mg.

Indications:

Prevention and treatment of nausea, vomiting, dizziness associated with motion sickness and vertigo.

Dosage and Administration:

The usual dose of Anosea (Meclizine Hydrochloride) are as follow-
Nausea and vomiting: 25-50 mg once daily or as directed by the physician.
Motion sickness: 25-50 mg once daily (1/2-1 tablet one hour before travel starts, the dose may be repeated every 24 hours for the duration of journey).
Vertigo: 25-100 mg daily, in divided doses.
Radiotherapy induced nausea and vomiting: 50 mg, 2 to 12 hours prior to radiotherapy.

Contraindication:

Meclizine Hydrochloride is contraindicated who have shown hypersensitivity to it.

Use in Pregnancy:

Epidemiological studies in pregnant women do not indicate that Meclizine Hydrochloride increases the risk of abnormalities when administered during pregnancy. It has been suggested that based on available data, Meclizine Hydrochloride presents the lowest risk of teratogenicity and is the drug of first choice in treating nausea and vomiting during pregnancy.

Lactating Mother:

Meclizine Hydrochloride may be distributed into breast milk. However problem in humans have not been documented.

Use in Children:

Clinical studies establishing safety and effectiveness in children have not been done, therefore, usage is not recommended in children under 12 years of age.

Adverse reaction:

Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.

Storage:

Keep in a cool and dry place, protected from light. Keep out of the reach of children.

Presentation:

Each box contain 5x10's and 10x10's tablet in blister pack.

Manufacturer’s Source: IBN SINA

Anodyne - Diclofenac Sodium: Enteric Coated Tablet and Sustained Release Capsule

2014-10-29T13:02:00.001+06:00

Description:
Anodyne® (Diclofenac Sodium) is one of the most important member of nonsteroidal antiinflammatory drug (NSAID). After taking Diclofenac, it absorbs from gastrointestinal tract and achieves peak plasma concentration within 2 hours. It inhibits the bio-synthesis of prostaglandin and thus acts as an analgesic.

Composition:
Anodyne® Tablet : Each tablet contains Diclofenac Sodium BP 50 mg.
Anodyne® -SR Capsule : Each SR Capsule contains Diclofenac Sodium BP
100mg in pellet form.

Indication:
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, lowback pain, dental pain, Post operative pain, dysmenorrhoea, biliary colic etc. and other acute musculo-skeletal disorders such as: frozen shoulder, tendonitis, teno-synovitis, bursitis, sprain, strain and dislocation.

Dosage and Administration:
1 tablet 3 times daily after meal or 1 SR Capsule once daily. In severe cases, two SR capsule may be given at 12 hour interval.

Precaution:
This type of drug should be given with caution in pregnant woman, lactating mother and those patients having a history of liver and kidney dysfunction and peptic ulcer.

Side effect:
Disturbance in stomach and intestine eg. epigastric pain, nausea, diarrhoea, dizziness, headache etc. may occur. Occasionally skin rash, peripheral oedema and abnormalitis of serum transaminase have been reported.

Contraindication:
Diclofenac is contraindicated in patients with peptic ulcer and in patients with known hypersensitivitis to Diclofenac. Besides if asthmatic attack increases due hypersensitivity to intake of Aspirin or this type of drug, in that case the drug must be avoided.

How supplied:
Anodyne® Tablet : Box contains 10x10's tablets in blister strip.
Anodyne® SR Capsule : Box contains 5 x 10's SR capsules in blister strip.

Manufacturer’s Source: IBN SINA

Anodyne Plus - Diclofenac Sodium BP and Lidocaine Hydrochloride USP Injection

2014-10-29T12:55:00.000+06:00

Description:
Anodyne® Plus is a potent non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. It also has some uricosuric effect. Diclofenac inhibits cyclooxygenase activity with a reduction in the tissue production of prostaglandins.

Composition:
Anodyne® Plus injection: Each 2 ml ampoule contains Diclofenac Sodium BP 75mg and Lidocaine Hydrochloride USP 20mg.

Indications:
Anodyne® Plus injection contains diclofenac sodium and is indicated in Rheumatoid arthritis, Osteoarthritis, Low back pain and other acute musculoskeletal disorders such as periarthritis (e.g. frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations, ankylosing spondylitis, acute gout, Control of pain and inflammation in orthopaedic, dental and other minor surgery, Juvenile rheumatoid arthritis, postoperative pain, renal colic pain & other uses.

Anodyne® Plus injection also contains lidocaine which is a widely used local anesthetic. Therefore, the possibility pain at the injection site which is most likely to occur after intramuscular injection of normal diclofanac, is minimized if Anodyne® Plus injection is used in the above indications.

Dosage and administration:
Adults : By deep I.M injection into the gluteal muscle, acute exacerbations and post-operative - One ampoule once daily (twice daily in severe cases) for max. of 2 days.
Renal /ureteric colic : One ampoule once daily intramuscularly. A further ampoule may be administered after 30 minutes, if necessary. Maximum daily dose: Diclofenac 150 mg, Lidocaine 200mg.
Children : In Juvenile chronic arthritis: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
Elderly patients : In elderly or debilitated patients, the lowest effective dosage is recommended, commensurate with age and physical status, or as prescribed by the physician.

Contraindications:
o Active peptic ulcer; asthma, aspirin or any non-steroid anti-inflammatory induced allergy.
o Previous sensitivity to diclofenac sodium
o Concomitant NSAID (intravenous use) or anticoagulant use (including lowdose heparin)
o Operations associated with a high risk of hemorrhage (intravenous use)
o Moderate or severe renal impairment (serum creatinine > 160 mmol. L-1), hypovolaemia or dehydration from any cause.

Side Effects:
Mild and infrequent gastro-intestinal discomfort, bleeding, nausea, vertigo, headache, hearing disturbances such as tinnitus; thrombocytopenia; hypersensitivity reactions.

Precaution:
History of gastrointestinal lesions; impaired renal function; pregnancy & lactation; concurrent administration of plasma protein-bound drugs, lithium, beta-blockers or frusemide.

Drug Interaction:
Potential hazardous interactions with lithium, digoxin, diuretics, methotrexate.

Storage condition
Keep in a cool and dry place protected from light.

How supplied:
Anodyne® Plus injection : 5 x 2's blistered 2 ml ampoules in a printed carton.

Manufacturer’s Source: IBN SINA

Anodyne - Diclofenac Sodium - Sterile Eye Drops

2014-10-29T11:10:00.000+06:00

Description:

Anodyne® Eye Drops is available as a sterile solution of Diclofenac Sodium having analgesic & antiinflammatory action. Diclofenac inhibits the cyclooxygenase enzyme essential for the biosynthesis of prostaglandin which is responsible for inflammation.

Composition:

Anodyne® Eye Drops : It contains Diclofenac Sodium BP 0.1% w/v.

Indication:

o Non infected inflammatory conditions affecting the anterior region of the eye.
o Post traumatic inflammation in penetrating and non-penetrating wounds as an adjuvant to local anti-infective therapy.
o Post operative inflammation in patients who have undergone cataract surgery and other surgical procedures.
o Inhibition of miosis during cataract surgery.
o Pre-operative & post operative prevention of cystoid macular oedema associated with lens extraction and intraocular lens implantation.

Dosage & Administration:
Pre-operative : Use upto 5 drops over 3 hours preceding surgery.
Post operative : Use 3 drops immediately after surgery, then 3 to 5 drops daily for as long as required.
Others : Use 4 to 5 drops daily, depending on the severity of the condition.
Children : No-specific investigation has been carried out.

Precaution:
Diclofenac eye drops should be used only after removal of contact lens in patients who use contact lens. If infection is present, appropriate treatment with antibiotic should be given concomitantly. The drug should not be prescribed during 3rd trimester of pregnancy.

Side effect:
Occasional mild to moderate transient stinging and blurred vision may occur after application of the Diclofenac eye drops. Hypersensitivity reaction in the form of itching, reddening and photosensitivity occur rarely.

Contraindication:
Diclofenac eye drops should not be used in patient with known hypersensitivityto Diclofenac or any of its excipients. Like other NSAID, Diclofenac is contraindicated in patients suffering from asthma, urticaria or acute rhinitis.

How supplied:
Anodyne® Eye Drops : Dropper bottle contains 5 ml drops.

Manufacturer’s Source: IBN SINA

Angiten – Captopril

2014-10-29T10:59:00.000+06:00

Description:
Angiten® is an antihypertensive drug, a highly specific competitive inhibitor of Angiotensin Converting Enzyme (ACE). It is extensively used in the management of hypertension and congestive cardiac failure. Angiten inhibits ACE and thus inhibits formation of Angiotensin-II which is a potent vasoconstrictor and thus reduces blood pressure through reducing total peripheral resistance.

Composition:
Each Angiten® tablet contains Captopril USP 25 mg.

Indication:
Angiten® is indicated in the management of -
Hypertension : Angiten® is indicated alone or in combination with thiazide diuretics in the management of hypertension.
Heart Failure : Angiten® can be used in heart failure in patients who have not responded adequately to or cannot be controlled by conventional diuretics or digitalis therapy.
Left Ventricular Dysfunction (LVD) after Ml : To improve survival following Ml (Myocardial infarction) in clinically stable patients with LVD and to reduce the incidence of overt heart failure and subsequent hospitalization in CHF, Angiten® can be used.
Diabetic Nephropathy : Angiten® is used for Diabetic Nephropathy (Proteinuria) with type-1 Insulin Dependent Diabetic Mellitus (IDDM) & Retinopathy.

Dosage & Administration:
Administer one hour before meal, if possible discontinue previous antihypertensive drug regimen one week before starting Captopril.

Hypertension :

In the treatment of hypertension, an initial dose is 12.5 mg twice daily by mouth, increased gradually at intervals of 2 to 4 weeks according to the response. The usual maintenance dose is 25 to 50 mg twice daily and should not normally exceed 50 mg three times daily. Even in more severe hypertension, addition of a second agent or substitution of an alternative drug, being preferred. (An initial dose of 6.25 mg twice daily is recommended if Captopril is given in addition to a diuretic, to elderly patients or to those with renal impairment.)

Heart Failure :

An initial dose of 6.25 to 12.5 mg of Captopril is given under close medical supervision. The usual maintenance dose is 25 mg two or three times daily and doses should not normally exceed 50 mg three times daily.

LVD After Ml :

The target maintenance dose is 50 mg thrice daily after a single starting dose of 6.25 mg and initially 12.5 mg thrice daily, then increase to 25 mg thrice daily during the next several days. Other post myocardial infarction therapies (eg. Thrombolytic agent, Aspirin, b-blocker) may be used concurrently.

Diabetic Nephropathy : Use 25 mg thrice daily of Captopril.

Precaution
Captopril should be used with great caution in patients with impaired renal function and patient with collagen vascular disorder, such as : systemic erythematous or scleroderma. Captopril is not recommended for children.

Side effect
The commonest adverse effects are skin rashes, persistent dry cough, loss of taste, sore mouth, angioedema, hypotension, abdominal pain, proteinurea, agranulocytosis, neutropenia and hyperkalaemia.

Contraindication
Captopril is contraindicated in patients who are hypersensitive to ACE inhibitors, in pregnancy and nursing mother and in patient with critical renovascular disease.

Drug interaction
Diuretics : Diuretics potentiate the antihypertensive effect of Captopril. Potassium sparing diuretics (Triamterene, Amiloride and Spironolactone) or Potassuim supplements may cause significant increase in serum Potassium.
Nonsteroidal anti-inflammatory agents : Concomitant therapy with Indomethacin and possibly other anti-inflammatory drugs may reduce the antihypertensive effect of Captopril.

How supplied
Angiten® Tablet : Box contains 10 x 10's tablets in blister strip. preferred.

Manufacturer’s Source: IBN SINA

Algirex- Etoricoxib Tablet

2014-10-29T10:45:00.000+06:00

Description:
Algirex is the preparation of Etoricoxib. It is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. It is a potent, orally active, highly selective cyclooxygenase-2 (COX-2) inhibitor within and above the clinical dose range. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by Etoricoxib decreases these clinical signs and symptoms with decreased GI toxicity and without effects on platelet function.

Composition:
Algirex® 60 Tablet: Each film-coated tablet contains Etoricoxib INN 60 mg.
Algirex® 90 Tablet: Each film-coated tablet contains Etoricoxib INN 90 mg.
Algirex® 120 Tablet: Each film-coated tablet contains Etoricoxib INN 120 mg.

Indication:
Acute pain and inflammation, Chronic musculo-skeletal pain, Osteoarthritis, Rheumatoid arthritis, Acute gouty arthritis, Primary dysmenorrhoea, Ankylosing spondylitis.

Dosage and Administration:
Adult and adolescent (over 16 years):
Arthritis:
Osteoarthritis: 60 mg once daily, Rheumatoid arthritis: 90 mg once daily, Acute gouty arthritis: 120 mg once daily.
Analgesia:
Acute pain associated with dental surgery: 120 mg once daily. Primary dysmenorrhoea, Chronic musculoskeletal pain, including chronic low back pain: 60 mg once daily.

Contraindication:
Patients with known hypersensitivity to Etoricoxib or to any of the excipients of this medicinal product. Active peptic ulceration or gastro-intestinal bleeding, severe hepatic dysfunction.
Children and adolescents under 16 years of age.
Patients with inflammatory bowel disease and severe congestive heart failure.

Precaution:
Decreased kidney function and liver function, dehydration, hypertension, history of heart failure, perforation and people over 65 years of age.

Side Effect:
Common side effects are dizziness, headache, gastro-intestinal disorders (e.g., abdominal pain, flatulence, heartburn), diarrhoea, dyspepsia, nausea, asthenia, fatigue, flu-like symptoms. Rare side effects are oedema, weight gain, anxiety, blurred vision, hypertension, epistaxis, dyspnoea, constipation, vomiting, muscle cramps, and chest pain.

Drug Interaction:
Warfarin, ACE inhibitor, Rifampicin, Lithium, birth control pills, Methotrexate, Digoxin.

Use in Pregnancy and Lactation:
Not recommended.

Storage:
Keep in a cool and dry place, protected from light and moisture.

Presentation:
Algirex® 60 Tablet: Each box contains 3 x 10's tablet in Alu-Alu blister strip.
Algirex® 90 Tablet: Each box contains 2 x 10's tablet in Alu-Alu blister strip.
Algirex® 120 Tablet: Each box contains 2 x 10's tablet in Alu-Alu blister strip.

Manufacturer’s Source: IBN SINA

Abex - Guaiphenesin, Pseudoephedrine & Triprolidine-Cough Expectorant

2014-10-29T00:38:00.000+06:00

Abex Syrup

Description:

Abex®Syrup is a mixture of expectorant, bronchodilator / decongestant and antihistamine. Guaiphenesin has an expectorant action and is thought to reduce sputum viscosity by increasing the volume and water content of the bronchial secretion, thereby facilitating the expectoration of sputum. Pseudoephedrine has direct and indirect sympathomimetic activity and is an effective upper respiratory decongestant, producing decongestion within 30 minutes which lasts for at least 4 hours. Triprolidine is a potent competitive histamine H1-receptor antagonist of the pyrrolidine group. Abex®Syrup is absorbed from the gastrointestinal tract. Guaiphenesin is metabolised and excreted in the urine. Pseudoephedrine is largely excreted unchanged in the urine together with small amount of its hepatic metabolite and Triprolidine is metabolised in the liver and excreted usually as metabolites in the urine.

Composition:

Each 5ml of Abex®Cough Syrup contains Guaiphenesin BP 100 mg, Pseudoephedrine HCl BP 30 mg and Triprolidine HCl BP 1.25 mg.

Indication:

Abex®Syrup is a cough preparation indicated for the symptomatic relief of upper respiratory tract disorder accompanied by productive cough which are benefited from the administration of an antihistamine, a decongestant and an expectorant combination.

Dosage and Administration:

Adult and Children over 12 years : 2 teaspoonful 3 times daily.

Children:6-12 years : 1 teaspoonful 3 times daily 2-5 years : 1/2 teaspoonful 3 times daily or as directed by the physician.

Precaution:

Abex®cough syrup may cause drowsiness; so patients should not drive or operate machineries. Concomitant use of alcohol and other centrally active durg should be avoided. Caution should be exercised in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement. The drug should not be used for persistent or chronic cough as occur with smoking, asthma or emphysema or where cough is accompanied by excessive secretions unless directed by a physician.

Use in pregnancy :

Caution should be exercised by balancing the potential benefit of treatment of the mother against any possible hazards to the developing foetus.

Side effect:

Central nervous system depression or excitation may occur, drowsiness being reported most frequently. Sleep disturbance and rarely hallucination have been reported. Skin rashes with or without irritation, tachycardia, dryness of mouth, nose and throat have occasionally been reported. Urinary retention has been reported occasionally in man receiving Pseudoephedrine; prostatic enlargement could have been an important predisposing factor.

Contraindication:

Abex®is contraindicated in patients with a known hypersensitivity to Guaiphenesin, Pseudoephedrine or Triprolidine. It is contraindicated in patients with severe hypertension or severe coronary artery disease. Also, contraindicated in persons who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks.

How supplied:

Abex®Cough Syrup : 100 ml Syrup available in bottle.

Manufacturer’s Source: IBN SINA