Human Health Division (HHD) Products

Product List by Generic Name
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Baclofen

Composition: MyobacTM 5 Tablet : Each tablet contains Baclofen USP 5 mg. MyobacTM 10 Tablet : Each tablet contains Baclofen USP 10 mg.

Pharmacology: MyobacTM (Baclofen) is an effective muscle relaxant and antispastic agent with a spinal site of action. It exerts its action by inhibiting both monosynaptic and polysynaptic transmission in the spinal cord by stimulating GABAB receptors.

Indications: MyobacTM (Baclofen) is indicated for the alleviation of spasticity resulting from multiple sclerosis particularly for the relief of flexor spasm and concomitant pain, clonus and muscular rigidity, spinal cord diseases, muscle spasm of cerebral origin especially infantile cerebral palsy, stroke or neoplastic or degenerative brain diseases. It may be of some value in patients with trigeminal neuralgia, tardive dyskinesia, cluster headache & tension type headache.

Dosage & Administration: Muscle relaxant & spasticity For adults: Start at a low dosage and increase gradually until the optimum effect is achieved (usually 40-80mg daily). Initially 5 mg three times daily for 3 days; then 10 mg three times daily for 3 days, 15 mg three times daily for 3 days and 20 mg three times daily for 3 days. Additional increases in dose may be required but should not exceed 20 mg four times daily. For Children: (treatment of spasticity): 0.75-2 mg/kg daily (over 10 years, max. 2.5 mg/kg daily) or 2.5 mg 4 times daily increased gradually according to age to maintenance: 1-2 years 10-20 mg daily, 2-6 years 20-30 mg daily, 6-10 years 30-60 mg daily. Or as directed by the physician. Contraindications: MyobacTM (Baclofen) is contraindicated in patients who are hypersensitive to any component of this preparation. Warning and precaution: Hallucinations and seizures may occur on abrupt withdrawal of MyobacTM (Baclofen). Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued. Side effects: Common side effects: Agitation, anxiety, ataxia, cardiovascular depression, confusion, depression, dizziness, drowsiness, dry mouth, euphoria, gastrointestinal disturbances, hallucinations, headache, hypotension, insomnia and myalgia. Rare side effects: Abdominal pain, changes in hepatic function, c, paraesthesia and taste disturbances.

Bilastine

Composition
Allertin 20 Tablet: Each tablet contains Bilastine INN 20 mg.
Allertin ODT 10: Each orally disintegrating tablet contains Bilastine INN 10 mg.
Allertin Oral Solution: Each ml oral solution contains Bilastine INN 2.5 mg.

Indication
Seasonal Allergic Rhinitis: Bilastine is indicated for the symptomatic relief of nasal and non-nasal symptoms  of seasonal allergic rhinitis (SAR) in patients of 4 years and older.
Chronic Spontaneous Urticaria: Bilastine is indicated for the relief of the symptoms associated with chronic spontaneous urticaria (CSU) (e.g. pruritus and hives), in patients of 4 years of age and older.

Dosage & Administration
Allertin 20 Tablet: Adults and adolescents 12 years of age and above: 20 mg tablet once daily. The tablet should be taken one hour before or two hours after intake of food.
Allertin Oral Solution: 4 ml of oral solution once daily for children 4 to 11 years of age. Recently, it has been approved in Latin America for children from 2 years of age. The oral solution should be taken one hour before or two hours after intake of food or fruit juice. Allertin ODT 10: The maximum recommended daily dose for children in
between 4 to 11 years is 10 mg Bilastine orally disintegrating tablet (1 tablet)  and  should  not  be  exceed.  If  a  dose  is  missed,  the  next scheduled dose should be taken. An extra dose is not necessary or as directed by the physician.

Bisoprolol + Hydroclorothiazide

Composition:
Tabis™ Plus 2.5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 2.5 mg and Hydrochlorothiazide BP 6.25 mg.
Tabis™ Plus 5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 5 mg and Hydrochlorothiazide BP 6.25 mg.

Indication:
Tabis™ Plus is indicated for the management of hypertension.

Dose & Administration:
The initial dose is 2.5/6.25 mg once daily. Subsequent titration (14 day intervals) may be carried out with Tabis™ Plus tablets up to the maximum recommended dose
20/12.5 mg once daily as appropriate.

Bisoprolol

Composition
Tabis™ 2.5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 2.5 mg.
Tabis™ 5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 5 mg

Indications
• Hypertension
• Angina
• Adjunct in stable moderate to severe heart failure.

Dose & Administration
Hypertension: The dose of Bisoprolol must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may be an appropriate starting dose. If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if
necessary, to 20 mg once daily.
Angina: Usually 10 mg once daily (5 mg may be adequate in some patients) max 20 mg daily.
Heart Failure: Initially 1.25 mg once daily (in the morning) for 1 week then, if well tolerated, increased to 2.5 mg once daily for 1 week, then 3.75 mg once daily for 1 week, then 5 mg once daily for 4 weeks, then 7.5 mg once daily for 4 weeks, then 10 mg once daily, max 10 mg daily.

Or as directed by the physician