Human Health Division (HHD) Products
Product List by Generic Name
Pregabalin Extended Release
Composition
Pregan ER 82.5: Each extended release tablet contains Pregabalin BP 82.5 mg.
Pregan ER 165: Each extended release tablet contains Pregabalin BP 165 mg.
Pharmacology
Pregabalin is a structural derivative of gamma-amino-butyric acid (GABA). It does not bind directly to GABA-A,
GABA-B, or benzodiazepine receptors. It binds with high affinity to the alpha 2-delta site (an auxilliary subunit of
voltage-gated calcium channels) in central nervous system tissues. Oral bioavailability of Pregabalin is 90%.
Pregabalin is eliminated largely by renal excretion and has an elimination half-life of about 6 hours. Pregabalin
can be taken with or without food.
Indication
Pregabalin Capsule- Neuralgia: (a) Pain from diabetic neuropathy, (b) Post-herpetic neuralgia Fibromyalgia
Partial seizure/Epilepsy.
Pregabalin ER Tablet- Diabetic peripheral neuropathy Post-herpetic neuralgia
Pravastatin
Composition
Pravalip 10 Tablet: Each tablet contains Pravastatin Sodium BP 10 mg.
Pravalip 20 Tablet: Each tablet contains Pravastatin Sodium BP 20 mg.
Pharmacology
Pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA)
reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate limiting step in the biosynthetic pathway for cholesterol. In addition, pravastatin reduces
VLDL and TG and increases HDL-C.
Indications
Pravalip is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
- Reduce the risk of Myocardial Infarction (MI), revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident Coronary Heart Disease (CHD).
- Reduce the risk of total mortality by reducing coronary death, Myocardial Infarction (MI), revascularization, stroke/Transient Ischemic Attack (TIA), and the progression of coronary atherosclerosis in patients with clinically evident Coronary Heart Disease (CHD).
- Reduce elevated Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Apolipoprotein B (ApoB) and Triglycerides (TG) levels and to increase High Density Lipoprotein Cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.
- Reduce elevated serum Triglycerides (TG) levels in patients with hypertriglyceridemia.
- Treat patients with primary dysbetalipoproteinemia who are not responding to diet.
- Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.
Dosage & Administration
Adults: The recommended starting dose is 40 mg once daily. Use 80 mg dose only for patients
not reaching LDL-C goal with 40 mg.
Significant renal impairment: The recommended starting dose of pravastatin is 10 mg once daily.
Children (ages 8 to 13 years): The recommended starting dose is 20 mg once daily.
Adolescents (ages 14 to 18 years): The recommended starting dose is 40 mg once daily or as directed by the physicians.
Pimecrolimus
Composition
Pmec Cream: Each gram cream contains Pimecrolimus INN 10 mg.
Pharmacology
The mechanism of action of Pimecrolimus in atopic dermatitis is not known. It has
been demonstrated that Pimecrolimus binds with macrophilin-12 (FKBP-12) and
inhibits the calcium-dependent phosphatase, calcineurin. As a consequence, it
inhibits T cell activation. In particular, Pimecrolimus inhibits Interleukin-2 and
Interferon gamma (Th1-type), Interleukin-4 and Interleukin-10 (Th2-type) cytokine
synthesis in human T cells. In addition, Pimecrolimus prevents the release of
inflammatory cytokines and mediators from mast cells in vitro after stimulation by
antigen/IgE.
Indication
Pmec Cream is indicated as second-line therapy for the short-term and
noncontinuous chronic treatment of mild to moderate atopic dermatitis in
non-immunocompromised adults and children 2 years of age and older, who have
failed to respond adequately to other topical prescription treatments or when those
treatments are not advisable.
Route of Administration
Topical use only
Dose & Administration
Skin should be cleaned before applying the cream. One finger tip unit (measured
by distance from the tip of an adult index finger to the first crease of that finger) to
be applied thinly and evenly on the affected area of skin twice daily. (PHYSICIAN
MAY ADJUST THE DOSE). Treatment should be stopped if signs and symptoms
(e.g. itch, rash and redness) resolve. If signs and symptoms persist and beyond 6
weeks, patients should be re-examined to confirm the diagnosis of atopic
dermatitis. A patient should not use sun lamps, tanning beds, or get treatment with
ultraviolet light therapy during treatment with Pmec Cream. Continuous long-term
use of Pimecrolimus should be avoided. A patient should not cover the skin being
treated with bandages, dressings or wraps. Loose fitting clothing that protects the
treated area from the sun are encouraged.
Potassium Citrate BP 30% & Citric Acid Monohydrate BP 5%
Composion:
KcitTM 200 ml oral solution: Each 5 ml solution contains Potassium Citrate BP 1500 mg and Citric Acid
Monohydrate BP 250 mg
Pharmacology:
Potassium Citrate and Citric Acid Monohydrate oral solution is a stable and pleasant-tasting oral systemic
alkalizer. Potassium Citrate is absorbed and metabolized to Potassium Bicarbonate, thus as a
systemic alkalizer. This product alkalinizes the urine without producing a systemic alkalosis in
recommended doses. Potassium Citrate does not neutralize the gastric juice or disturb digestion.
Indications:
- To relieve discomfort in urinary tract infections
-To prevent kidney stone With uricosuric agent to prevent gout
- Acidosis caused by kidney diseases
Dose & Administration
By mouth using oral solution
Adult: 10 mL 3 times a day, diluted well with water
Or as directed by the physician.
Polyethylene Glycol + Propylene Glycol
Composition
Syscol™ Sterile Eye Drops: Each ml contains
Polyethylene Glycol 400 USP 4 mg & Propylene
Glycol BP 3 mg.
Preservative: Sodium Perborate BP 0.001%
Indications
Syscol™ Sterile Eye Drops is indicated for the
temporary relief of burning and irritation due to
dryness of the eye.
Dosage and administration
Instill 1 drop 4 times daily in the affected eye(s) or as
needed or as directed by the physician.
Prucalopride
Composition
Prulicon™ 1Tablet: Each film coated tablet contains Prucalopride
Succinate INN equivalent to Prucalopride 1 mg.
Prulicon™2 Tablet: Each film coated tablet contains Prucalopride
Succinate INN equivalent to Prucalopride 2 mg.
Indication
Prulicon™ is indicated for symptomatic treatment of chronic
idiopathic constipation.
Dose & Administration
•Take with or without food.
•Recommended dosage by patient population:
Pregabalin
Composition
Pregan™ 50: Each capsule contains Pregabalin INN 50 mg.
Pregan™ 75: Each capsule contains Pregabalin INN 75 mg
Indication
• Neuralgia: (a) pain from diabetic neuropathy, (b) postherpetic neuralgia
• Fibromyalgia
• Partial seizure / epilepsy: Pregabalin is also indicated as adjunctive therapy for adult
patients with partial onset seizures.
• Generalized anxiety disorder
Dose & Administration
Neuropathic pain: Adult 18 years: Initially 150 mg daily in 2-3 divided doses, dose can be increased if necessary after 3-7 days to 300 mg daily in 2-3 divided doses and it can be
increased further if necessary after 7 days to max. 600 mg daily in 2-3 divided doses.
Epilepsy: Adult over 18 years: Initially 25 mg twice daily, dose can be increased at 7 day intervals in steps of 50 mg daily to 300 mg daily in 2-3 divided doses and it can be increased further of necessary after 7 days to max. 600 mg daily in 2-3 divided doses.
Generalized anxiety disorder: Adult over 18 years: Initially 150 mg daily in 2-3 divided doses, dose can be increased if necessary at 7 day intervals in steps of 150 mg daily; max. 600 mg daily in 2-3 divided doses.
Fibromyalgia: The recommended dose of Pregabalin is 300-450 mg/day. Initial dose is 75 mg twice daily and may be increased to 150 mg twice daily within 1 week based on efficacy and tolerability. Patient who does not experience sufficient benefit with 300 mg/ day may be further
increased to 225 mg twice daily. Or as directed by the physician.
Pizotifen
COMPOSITION :
Pizofen™ Tablet : Each film coated tablet contains Pizotifen
malate BP equivalent to Pizotifen 0.5 mg
Pizofen™ TS Tablet : Each film coated tablet contains Pizotifen
malate BP equivalent to Pizotifen 1.5 mg
INDICATION :
It is used as prophylactic treatment of vascular headaches of the migraine types, such as classic migraine, common migraine and cluster headache.
DOSE AND ADMINISTRATION :
Adult : Usually 1.5 mg daily, which may be taken as a single
dose at night or in three divided doses. Dose should be adjusted to individual patient's requirements. Upto a maximum of 4.5 mg may be given as a single dose daily.
Children : Dose is 1 mg as a single dose at night using 0.5 mg
tablet. Maximum dose is upto 1.5 mg daily usually in divided
dose.
Or as directed by the physician.
