Vietnam Product

Tigeron Tablets

Tigeron Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
- Hypertension
- Prophylaxis of chronic stable angina pectoris
- Prinzmetal's (variant) angina when diagnosed by a cardiologist

In hypertensive patients, Sampine has been used in combination with a thiazide diuretic, alpha blocker, beta-adrenoceptor blocking agent, or an angiotensin converting enzyme inhibitor. For angina, Sampine may be used as monotherapy or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and/or adequate doses of beta blockers.

Sampine is well tolerated in patients with heart failure and a history of hypertension or ischaemic heart disease.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

Dizziness, congestions, tachycardia, oedemas, headache, fatiguability, drowse, dyspnea, gastric pain, dyspepsia, nausea, constipation, dry mouth, liver function disorders, jaundice, pancreatitis, gums hyperplasia, non-specific skin reactions (skin itch, rash, erythema multiforme), alopecia, asthenia, arthralgia, myalgia, muscular spasms, convulsions, back pain, sexual disorders, impotence, dyspnea, pollakiuria, peripheral neuropathy, hyperhidrosis, gynecomastia, hyperglycemia, thrombocytopenia, vasculitis, angioneurotic oedema. Some isolated cases of retrosternal pain, cardiac infarction and arrhythmias (including ventricular tachyarrhythmia and atrial fibrillation) were described with Amlodipine referent medications in clinical trials.

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Warnings ad Precautions
Use carefully this medicine in patients with renal function disorders the period of half life of Amlodipine in such patients is increased. There is no need to change the dosage in patients with renal insufficiency the change of Amlodipine plasma concentration does not correlated with renal insufficiency severity. Amlodipine does not eliminated in haemodialysis.

Drug interactions:
Sampine can be used synchronously with thiazide diuretics, β-adrenoreceptors blockers, nitrates of durable action, sublingual nitroglycerine, nonsteroidal anti-inflammatory medicines, antibiotics and oral hypoglycemic medications.
Amlodipine does not change the concentration of digoxin in plasma and its renal clearance. The concomitant administration of Amlodipine with cimetidine does not change the pharmacokinetic of Amlodipine. The concomitant administration of Amlodipine with warfarin does not change the influents of warfarin to prothrombin time.
Grapefruit juice can increase the blood concentration of Amlodipine but this is not accompanied with clinically important blood pressure decrease.

What to do if you accidentally take too much (overdose) of the medicine?

In overdose the excessive peripheral vasodilation with arterial blood pressure decrease and reflex tachycardia can be. In case of severe arterial hypotension it should be conducted the measures to support the function of cardio-vascular system including the monitoring of cardiac and pulmonary function, diuresis and blood volume.
The activated carbon is prescribed (especially in the first 2 hours after the overdose), gastric lavage, physiological saline infusion therapy; if hypotension does not eliminated owing to these measures the vasopressors are prescribed in case of the absence of contraindications.
The intravenous calcium gluconate is indicted to remove the excessive calcium channels blocking. Because of the significant binding of Amlodipine with plasma proteins the haemodialysis is ineffective.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store below 30°C.

Drug Description

Active substances:
S(-)Amlodipine Besilate
Each uncoated tablet contains;
S(-)Amlodipine Besilate equivalent to S(-)Amlodipine ………… 2.5 mg
Excipients:
MCC PH 102, Cross Carmellose Sodium, Colloidal Anhydrous Silicon, Stearic Acid.

Indications and dosage.

INDICATIONS:
- Hypertension
- Prophylaxis of chronic stable angina pectoris
- Prinzmetal's (variant) angina when diagnosed by a cardiologist
In hypertensive patients, Sampine has been used in combination with a thiazide diuretic, alpha blocker, beta-adrenoceptor blocking agent, or an angiotensin converting enzyme inhibitor. For angina, Sampine may be used as monotherapy or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and/or adequate doses of beta blockers.
Sampine is well tolerated in patients with heart failure and a history of hypertension or ischaemic heart disease.

DOSAGE:
The initial dose of Sampine is 2.5 – 5 mg once in a day.
The dose can be increased up the maximal – 10 mg per day according to the clinical need.
There is no need to decrease the dose for the patients with renal disorders.
In case of the liver function pathology the medication should be prescribed in minimal dose 2.5 mg per day.
The recommended dose for elderly patients is 2.5 – 5 mg per day.
The level of arterial blood pressure should be controlled daily in course of the treatment.

Side effects and drug interactions.

ADVERSE REACTIONS:
Dizziness, congestions, tachycardia, oedemas, headache, fatiguability, drowse, dyspnea, gastric pain, dyspepsia, nausea, constipation, dry mouth, liver function disorders, jaundice, pancreatitis, gums hyperplasia, non-specific skin reactions (skin itch, rash, erythema multiforme), alopecia, asthenia, arthralgia, myalgia, muscular spasms, convulsions, back pain, sexual disorders, impotence, dyspnea, pollakiuria, peripheral neuropathy, hyperhidrosis, gynecomastia, hyperglycemia, thrombocytopenia, vasculitis, angioneurotic oedema. Some isolated cases of retrosternal pain, cardiac infarction and arrhythmias (including ventricular tachyarrhythmia and atrial fibrillation) were described with Amlodipine referent medications in clinical trials.

Drug interactions:
Sampine can be used synchronously with thiazide diuretics, β-adrenoreceptors blockers, nitrates of durable action, sublingual nitroglycerine, nonsteroidal anti-inflammatory medicines, antibiotics and oral hypoglycemic medications.

Amlodipine does not change the concentration of digoxin in plasma and its renal clearance.

The concomitant administration of Amlodipine with cimetidine does not change the pharmacokinetic of Amlodipine.

The concomitant administration of Amlodipine with warfarin does not change the influents of warfarin to prothrombin time.

Grapefruit juice can increase the blood concentration of Amlodipine but this is not accompanied with clinically important blood pressure decrease.

Warnings and precautions

Use carefully this medicine in patients with renal function disorders the period of half life of Amlodipine in such patients is increased. There is no need to change the dosage in patients with renal insufficiency the change of Amlodipine plasma concentration does not correlated with renal insufficiency severity. Amlodipine does not eliminated in haemodialysis.

Overdosage and Contraindications

Overdose:
In overdose the excessive peripheral vasodilation with arterial blood pressure decrease and reflex tachycardia can be. In case of severe arterial hypotension it should be conducted the measures to support the function of cardio-vascular system including the monitoring of cardiac and pulmonary function, diuresis and blood volume. The activated carbon is prescribed (especially in the first 2 hours after the overdose), gastric lavage, physiological saline infusion therapy; if hypotension does not eliminated owing to these measures the vasopressors are prescribed in case of the absence of contraindications.

The intravenous calcium gluconate is indicted to remove the excessive calcium channels blocking. Because of the significant binding of Amlodipine with plasma proteins the haemodialysis is ineffective.

CONTRAINDICATIONS:
Sampine is contra-indicated in patients with a known sensitivity to S(-)Amlodipine and other medication components or other dihydropyridines, severe arterial hypotension, instable stenocardia, aortic stenosis with hemodynamics disorders, pregnancy, lactation, age under 18 years old.

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:
Pharmacodynamics.Amlodipine is the antagonist of calcium ions (the blocker of slow calcium membrane channels) which is blocked the movement of calcium ions into the cells of smooth muscles of myocardium and vessels. Therefore Amlodipine provides the direct influence on the targets.
The antianginal effect of Amlodipine is reached owing to firstly the dilatation of peripheral arteriole and therefore the reducing of the afterload. Because of the heart rate in that is almost unchanged the reducing of the afterload causes the reduction of the power inputs and oxygen needs correspondingly.
Secondly, Amlodipine directly dilates the coronary arterias both in intact and ischemic myocardium that causes the oxygen access to ischemic myocardium in patients with angiospasticstenocardia (Prinzmetal'sstenocardia). The single use of Amlodipine in patients with arterial hypertension provides the clinically important reducing of blood pressure for 24 hours. Amlodipine acts gradually and usually does not cause the symptomatic hypotension. The single use of Amlodipine increases the period of physical training tolerance, retards the attack of stenocardia and segment ST depression during physical activity, decreases the frequency of stenocardia attacks and need of nitroglycerine.
Amlodipine does not have any negative influence on the metabolism and plasma lipid composition, it can be used in the treatment of patients with alimentary diabetes and podagra.
Pharmacokinetics.Amlodipine is rapidly absorbed from the gastrointestinal tract after the oral usage and reached the maximal plasma concentration within 6 – 12 hours. Food does not influent on the Amlodipine absorption. The bioavailability is 64 – 80%. The distribution volume is near about 21 l/kg. Approximately 97.5% of Amlodipine binds with plasma proteins. Steady-state concentration in plasma is reached after 7 – 8 days of the regular use. Amlodipine is transformed to inactive metabolites in the liver, in that 10% of unchanged substance and 60% metabolites are excreted with urine. The period of half life is approx. 35 – 50 hours that can use this medicine 1 time per day.

PHARMACEUTICAL CHARACTERISTICS:
General physic-chemical properties:
orange capsule-like tablets with white speckles.

Shelf-life:
2 years from the date of manufacture.

Storage:
Store below 300C.
Keep out of reach of children.

Package:
Supplied in Alu-Alu blister of 14's tablets. Two such strips are packed in a carton along with package insert.
Conditions of supply.
By prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780