Human Health Division (HHD) Products
Product List by Brand Name
Ezitor
Composition
Ezitor 10/10: Each film coated tablet contains Ezetimibe USP 10 mg and Atorvastatin
calcium USP equivalent to Atorvastatin 10 mg.
Ezitor 10/20: Each film coated tablet contains Ezetimibe USP 10 mg and Atorvastatin
calcium USP equivalent to Atorvastatin 20 mg.
Pharmacology
Ezitor is a combination of Ezetimibe and Atorvastatin. Ezetimibe reduces blood cholesterol
by inhibiting the absorption of cholesterol by the small intestine. Ezetimibe is localized at
the brush border of the small intestine and inhibits the absorption of cholesterol, leading to
a decrease in the delivery of intestinal cholesterol to the liver. This causes a reduction of
hepatic cholesterol stores and an increase in LDL receptors, resulting in clearance of
cholesterol from the blood.
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase. The rate-limiting
enzyme responsible for the conversion of 3-hydroxy-3-methyl-glutaryl-coenzyme A to
mevalonate, a precursor of sterols, including cholesterol. Triglycerides (TG) and cholesterol
in the liver are incorporated into VLDL and released into the plasma for delivery to
peripheral tissues. Low-density lipoprotein (LDL) is formed from VLDL and is catabolised
primarily through the high affinity LDL receptor. Atorvastatin lowers plasma cholesterol and
lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver
and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake
and catabolism of LDL.
Indication
Ezitor is indicated as adjunctive therapy to diet to:
• reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in
patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed
hyperlipidemia.
• reduce elevated total-C and LDL-C in patients with homozygous familial
hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments.
Dosage and Administration
• Dosage range is 10/10 mg/day through 10/80 mg/day.
• Recommended starting dose is 10/10 mg/day or 10/20 mg/day.
• Recommended starting dose is 10/40 mg/day for patients requiring a greater than 55%
reduction in LDL-C or as directed by the physician.
Ertuglif
Composition
Ertuglif 5: Each film coated tablet contains Ertugliflozin L-Pyroglutamic Acid INN equivalent to Ertugliflozin 5 mg.
Pharmacology
SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Ertugliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, ertugliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion.
Indication
Ertugliflozin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults
with type 2 diabetes mellitus.
Dosage & Administration
The recommended starting dose of Ertugliflozin is 5 mg once daily taken in the morning with or
without food. In patients tolerating Ertugliflozin 5 mg once daily, the dose may be increased to a
maximum recommended dose of 15 mg once daily if additional glycaemic control is needed or as directed by the physician.
Contraindications
Severe renal impairment, end-stage renal disease (ESRD) or dialysis. History of a serious
hypersensitivity reaction to Ertugliflozin.
Use in Pregnancy & Lactation
Pregnancy: Ertugliflozin is not recommended during the second and third trimesters of
pregnancy. The limited available data with Ertugliflozin in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. There are risks to the
mother and fetus associated with poorly controlled diabetes in pregnancy.
Lactation: Ertugliflozin is not recommended while breastfeeding.
Use in Children & Adolescents
Pediatric Use: Safety and effectiveness of Ertugliflozin in pediatric patients under 18 years of age have not been established.
Geriatric Use: No dosage adjustment of Ertugliflozin is recommended based on age.
Drug Interactions
Concomitant Use with Insulin and Insulin Secretagogues Ertugliflozin may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with Ertugliflozin.
Overdosage
In the event of an overdose with Ertugliflozin contact the Poison Control Center. Employ the usual supportive measures as dictated by the patient’s clinical status. Removal of ertugliflozin by hemodialysis has not been studied.
Storage
Store below 30°C, away from light and in a dry place. Keep all medicines out of the reach of
children.
Esotac Tablet, Capsule & Injection
Composition
Esotac20 Capsule: Each delayed release capsule contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg.
Esotac40 Capsule: Each delayed release capsule contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 40 mg.
Esotac20 Tablet: Each enteric coated tablet contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg.
Esotac40 Tablet: Each enteric coated tablet contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 40 mg.
Indication
1. Healing of erosive esophagitis
2. Long-term management of esophagitis
3. Symptomatic gastroesophageal reflux disease
4. H. pylori eradication for the treatment of duodenal ulcer (Triple therapy with Esomeprazole,
clarithromycin and amoxicillin)
Dose and Administration
Healing of erosive Esophagitis: 20 mg or 40 mg once daily for 4-8 weeks. For those patients who have not healed after 4-8 weeks of treatment, an additional 4-8 weeks course of Esomeprazole may be considered.Long-term management of esophagitis: 20 mg once daily. Symptomatic gastroesophageal reflux disease: 20 mg once daily for 4 weeks.
H. pylori eradication for the treatment of duodenal ulcer (Triple therapy): 20 mg Esomeprazole once daily with 500 mg clarithromycin twice daily and 1g amoxicillin twice daily for 7-10 days or as directed by the physician
Esona
Composition
Esona™ 375/20 Tablet: Each tablet contains Naproxen BP 375 mg & Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg.
Esona™ 500/20 Tablet: Each tablet contains Naproxen BP 500 mg & Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg.
Indication
It is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, dysmenorrhoea and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers.
Dosage and Administration
Carefully consider the potential benefits and risks of Esona™ and other treatment options before deciding to use Esona™. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. If a dose of Esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered.
