Products – Page 2 – AGP Pharma

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AG-Vono

Generic:

Vonoprazan

Therapeutic Class:

Proton Pump Inhibitor

Composition:

Each AG-Vono tablet contains 10 mg or 20 mg of Vonoprazan.

Description:

AG-Vono (Vonoprazan) is a first-in-class potassium-competitive acid blocker medication.

Indications:

AG-Vono is indicated for:

Treatment of gastric ulcer
Treatment of duodenal ulcer
Treatment of reflux esophagitis
Maintenance treatment of reflux esophagitis in patients with repeat recurrence and relapse of the condition
Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration
Adjunctive effect on eradication of Helicobacter pylori

Dosage:

Adults

Gastric ulcer
• The usual dose is AG-Vono Tab 20 mg once daily. Administration – Limited to 8 weeks.Duodenal ulcer
• The usual dose is AG-Vono Tab 20 mg once daily. Administration – Limited to 6 weeks.

Reflux esophagitis (erosive esophagitis)
• The usual dose is AG-Vono Tab 20 mg once daily. Administration – Limited to 4 – 8 weeks.

• In addition, for the maintenance of healing of reflux esophagitis in patients with repeat recurrence and relapse of the condition, a dose of AG-Vono Tab 10 mg is administered once daily; however, when the efficacy is inadequate, a dose of AG-Vono Tab 20 mg may be administered once daily. The duration of administration in the long-term efficacy clinical Study is up to 52 weeks.

Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration
• The usual dose is AG-Vono Tab 10 mg once daily.

Adjunct to Helicobacter pylori eradication
• Usually, the following 3 drugs are orally administered at the same time twice daily for 7 days: AG-Vono Tab 20 mg, 750 mg amoxicillin, and 200 mg clarithromycin. The dose of clarithromycin may be appropriately increased as required, however, the upper limit is 400 mg twice daily.

• If the treatment with 3 drugs consisting of a proton pump inhibitor, amoxicillin, and clarithromycin fails, alternative treatment with the following 3 drugs is recommended; AG-Vono Tab 20 mg, 750 mg amoxicillin, and 250 mg metronidazole, orally administered at the same time twice daily for 7 days. The doses of antibiotic should follow the respective label recommendations for H. pylori eradication.

Presentations:

AG-Vono Tab 10 mg & Tab 20 mg are available in blister pack of 14’s

PeriDots

Generic:

Peppermint oil, Spearmint oil

Therapeutic Class:

Menthae Piperitae Aetheroleum

Composition:

Each PeriDots soft gelatin capsule contains:

Peppermint oil .……………. 0.174 ml
Spearmint oil ……………. 0.034 ml

Description:

Peppermint oil is the essential oil taken from the flowering parts and leaves of the peppermint plant. Peppermint is used to treat a variety of digestive problems such as heartburn and acidity. Also, it has antispasmodic activity. It provides quick relief from acidity, bloating, etc. Effective solution for indigestion and pain.

Indications:

Indigestion
Heartburn
Acidity
Excessive gas
Abdominal spasm and colic pain

Dosage:

To be taken after a meal with a glass of water.
1 capsule: 2-3 times daily
Not recommended for children below 12 years of age

Presentations:

PeriDots Cap is available in packs of 30’s.

Rozet EZ

Generic:

Rosuvastatin, Ezetimibe

Therapeutic Class:

Lipid Modifying Agents, Combinations

Composition:

Rozet EZ Tab 5 mg / 10 mg: Each tablet contains 5 mg Rosuvastatin and 10 mg Ezetimibe.
Rozet EZ Tab 10 mg / 10 mg: Each tablet contains 10 mg Rosuvastatin and 10 mg Ezetimibe.
Rozet EZ Tab 20 mg / 10 mg: Each tablet contains 20 mg Rosuvastatin and 10 mg Ezetimibe.

Description:

Rozet EZ tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor.

Indications:

As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C).
Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Dosage:

The dosage range is 5 mg/10 mg to 40 mg/10 mg once daily.

The recommended dose of Rozet EZ depends on a patient’s indication for usage, LDL-C, and individual risk for cardiovascular events.
The starting dosage for patients switching to Rozet EZ from co-administration of a statin and ezetimibe is based on an equivalent dose of rosuvastatin and 10 mg of ezetimibe.
Assess LDL-C when clinically appropriate, as early as 2 weeks after initiating Rozet EZ, and adjust the dosage if necessary.

Presentations:

Rozet EZ Tab 5 mg /10 mg is available in a pack of 10’s
Rozet EZ Tab 10 mg /10 mg is available in a pack of 10’s
Rozet EZ Tab 20 mg /10 mg is available in a pack of 10’s

Xiton

Generic:

Risperidone

Therapeutic Class:

Atypical Antipsychotics

Composition:

Each Xiton tablet contains risperidone 1 mg, 2 mg, 3 mg or 4 mg as active ingredient
Each ml of Xiton oral solution contains risperidone 1 mg

Description:

Xiton (Risperidone), an atypical antipsychotic belongs to the chemical class of benzisoxazole derivatives.

Indications:

Schizophrenia
Bipolar Mania
- Monotherapy: Acute manic or mixed episodes associated with Bipolar I Disorder.
- Adjunctive Therapy: With lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.
Irritability Associated with Autistic Disorder

Dosage:

	Initial Dose	Titration (Increments)	Target Dose	Effective Dose Range
Schizophrenia: Adults	2 mg	1 to 2 mg	4 to 8 mg	4 to 16 mg
Schizophrenia: Adolescents	0.5 mg	0.5 to 1 mg	3 mg	1 to 6 mg
Bipolar Mania: Adults	2 to 3 mg	1 mg	1 to 6 mg	1 to 6 mg
Bipolar Mania: Children and Adolescents	0.5 mg	0.5 to 1 mg	1 to 2.5 mg	1 to 6 mg
Irritability in Autistic Disorder	0.25 mg Can increase to 0.5 mg by Day 4: (body weight less than 20 kg) 0.5 mg Can increase to 1 mg by Day 4: (body weight greater than or equal to 20 kg)	After Day 4, at intervals of > 2 weeks: 0.25 mg (body weight less than 20 kg) 0.5 mg (body weight greater than or equal to 20 kg)	0.5 mg: (body weight less than 20 kg) 1 mg: (body weight greater than or equal to 20 kg)	0.5 to 3 mg

Presentations:

Xiton Tabs 1 mg, 2 mg, 3 mg or 4 mg are available in pack of 10’s.
Xiton Oral Solution is available in 60 ml bottle.

Xedexo

Generic:

Olanzapine, Fluoxetine

Therapeutic Class:

Psycholeptic Antidepressant

Composition:

Xedexo Cap 3 mg/ 25 mg: Each capsule contains 3 mg Olanzapine with 25 mg Fluoxetine.
Xedexo Cap 6 mg/ 25 mg: Each capsule contains 6 mg Olanzapine with 25 mg Fluoxetine.

Description:

Xedexo contains Olanzapine and Fluoxetine an atypical antipsychotic and a selective serotonin reuptake inhibitor.

Indications:

• Acute depressive episodes in Bipolar I Disorder
• Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode)

Dosage:

Depressive Episodes Associated with Bipolar I Disorder:

Adults: One capsule daily in the evening, generally beginning with the 6 mg/25 mg capsule.

Children and adolescents (10 to 17 years of age): One capsule daily in the evening, generally beginning with the 3 mg/25 mg capsule.

Treatment Resistant Depression:

Administer one capsule daily in the evening, generally beginning with the 6 mg/25 mg capsule. Adjust dosage, if indicated, according to efficacy and tolerability.

Presentations:

Xedexo Cap 3 mg/25 mg & 6 mg/25 mg are available in pack of 14’s

TruGlif

Generic:

Empagliflozin

Therapeutic Class:

SGLT2 Inhibitors Antidiabetic Plain

Composition:

Each TruGlif tablet contains 10 mg or 25 mg of Empagliflozin

Description:

TruGlif tablets contain empagliflozin, an orally active inhibitor of the Sodium-Glucose Co-Transporter 2 (SGLT2).

Indications:

TruGlif is indicated:

• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Limitation of Use:
Not for the treatment of type 1 diabetes mellitus and/or diabetic ketoacidosis.

Dosage:

The recommended dose of TruGlif is 10 mg once daily in the morning, taken with or without food. In individuals tolerating TruGlif, the dose may be increased up to 25 mg or as directed by the physician.

Presentations:

TruGlif Tablets 10 mg & 25 mg are available in pack of 14’s

TruGlif Met

Generic:

Empagliflozin, Metformin HCl

Therapeutic Class:

SGLT2 Inhibitors & Biguanide Combs

Composition:

TruGlif Met Tab 12.5 mg /500 mg: Each tablet contains 12.5 mg Empagliflozin and 500 mg Metformin HCl.
TruGlif Met Tab 12.5 mg /1000 mg: Each tablet contains 12.5 mg Empagliflozin and 1000 mg Metformin HCl.

Description:

TruGlif Met (Empagliflozin and metformin) is used with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes.

Indications:

TruGlif Met is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise:

• In patients insufficiently controlled on their maximally tolerated dose of metformin alone

• In combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products

• In patients already being treated with the combination of empagliflozin and metformin as separate tablets.

Dosage:

The maximum recommended dose is 12.5 mg empagliflozin and 1000 mg metformin HCl twice daily. Take twice daily with meals, with gradual dose escalation to reduce the gastrointestinal side effects due to metformin.

Adults with normal renal function (GFR ≥90 ml/min)

The recommended dose is one tablet twice daily. The dosage should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability using the recommended daily dose of 10 mg or 25 mg of empagliflozin, while not exceeding the maximum recommended daily dose of metformin.

For patients switching from separate tablets of empagliflozin and metformin

Patients switching from separate tablets of empagliflozin and metformin should receive the same daily dose of empagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.

Renal impairment

Not recommended in patients with an eGFR less than 45 mL/min/1.73 m2, due to the metformin component

Presentations:

TruGlif Met Tablets 12.5 mg / 500 mg available in pack of 14’s.
TruGlif Met Tablets 12.5 mg /1000 mg available in pack of 14’s.

Daplazole

Generic:

Dexlansoprazole

Therapeutic Class:

Proton Pump Inhibitor

Composition:

Each Daplazole cap contains 30 or 60 mg of dexlansoprazole.

Description:

Daplazole (Dexlansoprazole) belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H+, K+)-ATPase at the secretory surface of the gastric parietal cell.

Indications:

Healing of Erosive Esophagitis:

Indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks.

Maintenance of Healed Erosive Esophagitis and Relief of Heartburn:

Indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age.

Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease:

Indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks

Dosage:

Recommended Dosage Regimen by Indication in Patients 12 Years of Age and Older

Indication	Dosage	Duration
Healing of Erosive Esophagitis	One 60 mg capsule once daily.	Up to 8 weeks
Maintenance of Healed Erosive Esophagitis and Relief of Heartburn	One 30 mg capsule once daily	Controlled studies did not extend beyond 6 months in adults and 16 weeks in patients 12 to 17 years of age.
Symptomatic Non-Erosive Gastroesophageal Reflux Disease	One 30 mg capsule once daily.	4 weeks

Presentations:

Daplazole Caps 30 mg & 60 mg are available in pack of 30’s

Imuzer

Generic:

Vitamin C, Zinc

Therapeutic Class:

Vitamin C Combinations

Composition:

Each Imuzer sachet contains:

Vitamin C … 300 mg
Zinc ……….. 5 mg

Each Tablet contains:

Vitamin C…… 500 mg
Zinc ………….10 mg

Each Chewable Tablet contains:

Vitamin C…….300 mg
Zinc ………….5 mg

Description:

Imuzer tablets and sachet contains Vitamin C & Zinc. Vitamin C, also known as L-ascorbic acid, is a water-soluble vitamin that is naturally present in some foods, added to others, and available as a dietary supplement. Humans are unable to synthesize vitamin C, so it is an essential dietary component.

Zinc is a mineral that is commonly added to supplements and other healthcare products that are meant to boost immune system. Supplementation with Zinc and Vitamin C is vital for immune health and may help protect against respiratory tract infections and reduce the duration of these infections

Indications:

Immunity booster in cold, flu and other viral infections
To reduce the risk of preterm birth
Mood stabilization particularly in women

Dosage:

1-2 Sachets daily or as prescribed by the Physician
1-2 Tabs/sachets daily or as prescribed by the Physician

Presentations:

Imuzer Sachet is available in a pack of 30’s.
Imuzer Tab is available in a pack of 60’s.
Imuzer Chewable Tab is available in a pack of 60’s.

Clozaril

Generic:

Clozapine

Therapeutic Class:

Atypical Antipsychotics

Composition:

Each Clozaril tablet contains 25 mg or 100 mg of clozapine.

Description:

Clozaril (clozapine) is an atypical antipsychotic drug.

Indications:

Treatment-resistant schizophrenia

Clozaril is indicated in adult patients with treatment-resistant schizophrenia, i.e. patients with schizophrenia who are non-responsive to or intolerant of classic antipsychotics.

Dosage:

The dosage must be adjusted individually. For each patient the lowest effective dose should be used. In patients with a history of seizures or suffering from renal or cardiovascular disorders (note: severe renal or cardiovascular disorders are contraindications) the initial dose should be 12.5 mg given once on the first day, and dosage increase should be slow and in small increments.

Starting therapy:

Clozaril should be started with 12.5 mg (half a 25 mg tablet) once or twice on the first day, followed by one or two 25 mg tablets on the second day. If well tolerated, the daily dose may then be increased slowly in increments of 25 mg to 50 mg in order to achieve a dose level of up to 300 mg/day within 2 to 3 weeks. Thereafter, if required, the daily dose may be further increased in increments of 50 mg to 100 mg at half-weekly or, preferably, weekly intervals.

Therapeutic dose range:

In most patients, antipsychotic efficacy can be expected with 200 to 450 mg/day given in divided doses. Some patients may be treated with lower doses, and some patients may require doses up to 600 mg/day. The total daily dose may be divided unevenly, with the larger portion being taken at bedtime.

Maximum dose:

To obtain full therapeutic benefit, a few patients may require larger doses, in which case judicious increments (not exceeding 100 mg) are permissible up to 900 mg/day. The possibility of increased adverse reactions (in particular seizures) occurring at doses over 450 mg/day must be borne in mind.

Maintenance dose:

After achieving maximum therapeutic benefit, patients can be maintained effectively on lower doses. Careful downward titration is recommended to the lowest effective dose for the individual patient. Treatment should be maintained for at least 6 months. If the daily dose does not exceed 200 mg, once daily administration in the evening may be appropriate.

Ending therapy:

In the event of planned termination of Clozaril therapy, a gradual reduction in dose over a 1- to 2- week period is recommended.

Re-starting therapy:

In patients in whom the interval since the last dose of Clozaril exceeds 2 days, treatment should be re-initiated with 12.5 mg (half a 25 mg tablet) given once or twice on the first day.

Presentations:

Clozaril Tab 25 mg & 100 mg are available in blister packs of 50’s