Amlong Amlodipine Tablets

Amlong AMLODIPINE TABLETS

Composition, Pharmacological category, Pharmacology, Pharmacokinetics, Indications, Contraindications, Side effects, Adverse effects, Precautions, Warnings, Drug interactions, Pregnancy and lactation effects, Dosage and administration, Overdosage, symptoms and antidote, Storage, Presentation, Owners and Manufacturer of Amlong Tablet Medicine for Hypertension.

 

COMPOSITION

Amlong-5: Each tablet contains: Amlodipine Besilate BP equivalent to Amlodipine 5mg
Amlong-10: Each tablet contains: Amlodipine Besilate BP equivalent to Amlodipine 10mg

 

PHARMACOLOGICAL CATEGORY

A Long-acting Calcium Channel Blocker.

 

PHARMACOLOGY

Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into the vascular smooth muscle and cardiac muscle. The mechanism of the antihypertensive action is due to a direct relaxant effect on vascular smooth muscle. The precise mechanism by which Amlodipine relieves angina may be due to the following two actions:

1. Amlodipine dilates peripheral arterioles and thus reduces the total peripheral resistance against which the heart works. Since there is no associated reflex tachycardia, this unloading of the heart reduces myocardial energy consumption and oxygen requirements and probably accounts for the effectiveness of Amlodipine in myocardial ischaemia.

2. The mechanism of action of Amlodipine probably involves dilation of the main coronary arteries and coronary arterioles, both in normal and ischaemic regions.

 

PHARMACOKINETICS

After oral administration of the therapeutic doses, Amlodipine is well absorbed with peak blood levels between 6-12 hours post dose. The volume of distribution was approximately 20 liters per kg. The terminal elimination half-life is about 35-50 hours and is consistent with once daily dosing, steady state plasma levels are reached after 7-8 days of consecutive dosing. Amlodipine is extensively metabolised to inactive metabolites with 10% of the parent compound and 60% of metabolites excreted in the urine. Bioavailability following oral administration is approximately 60-65%. Approximately 97.5% of the drug is bound to plasma proteins.

 

INDICATIONS AND USES

Amlodlpine is indicated in treatment of Hypertension and Myocardial Ischaemia associated with angina pectoris.

 

CONTRAINDICATIONS

Amlodipine is contraindicated in patients with known hypersensitivity to Amlodipine.

 

SIDE EFFECTS/ADVERSE EFFECTS

The most commonly observed side effects were headache, oedema, fatigue, nausea, flushing and dizziness.

 

PRECAUTIONS/WARNINGS

Increased Angina and/or Myocardial infarction: Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated.

 

DRUG INTERACTIONS

Amlodipine has been safely administered with thiazide diuretics, beta-adrenoceptor blocking drugs, angiotensin converting enzyme inhibitor, long acting nitrates, sublingual glyceryl nitrate, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycaemic agents. Co-administration of Cimetidine did not alter the pharmacokinetics of Amlodipine. In vitro data from studies with human plasma indicate that Amlodipine has no effect on protein binding of Digoxin, Phenytoin, Warfarin, or Indomethacin.

 

USE IN PREGNANCY AND LACTATION

Safety of Amlodipine in human pregnancy and lactation has not been established. Therefore, Amlodipine should not be administered during pregnancy, or lactation, or to women of child bearing potential unless effective contraception is used.

 

DOSAGE AND ADMINISTRATION

Adults: For both hypertension and angina, the recommended initial dose is 5mg Amlodipine orally once daily which may be increased to a maximum dose of 10mg depending on the individual patient’s response. The dose does not need adjusting when Amlodipine is given concurrently with thiazide diuretics, beta-adrenoreceptor blocking agents or angiotensin-converting enzyme inhibitors. Amlodipine can be administered with or without food.

Use in children: Since there is no clinical experience in patients of less than 18 years, use in children is not currently recommended.

Use in the elderly: Although elderly patients may have higher plasma concentration of Amlodipine than younger patients, the terminal elimination half-lives are similar. Amlodipine is similarly well tolerated in elderly or younger patients. Therefore the normal dosage is recommended.

Use with renal Impairment: Changes in Amlodipine plasma concentration are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amlodipine is not dialysable.

Use in patients with impaired hepatic function: The half-life of Amlodipine in patients with impaired liver function and dosage recommendation have not been established. Amlodipine should therefore be administered with caution in these patients.

 

OVERDOSAGE, SYMPTOMS AND ANTIDOTE

There is no documented experience with Amlodipine overdosage. Since Amlodipine absorption is slow, gastric lava-may be worthwhile in some cases. Available data suggest that gross overdosage would result in excessive peripheral vasodilation with subsequent marked and probably prolonged systemic hypotension. Clinically significant hypotension due to Amlodipine overdosage calls for active cardiovascular support including monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output. A vasoconstrictor agent may be helpful in restoring vascular tone and blood pressure provided that there is no contraindication to its use. Since Amlodipine is highly protein-bound, dialysis is unlikely to be of benefit.

 

STORAGE

Keep in a cool, dry place. Keep out from the reach of children.

 

PRESENTATION

Alu Alu Blister pack of 1 x 10’s, 3 x 10’s and 10 x 10’s.

 

DATE OF PUBLICATION

February 2016.


Manufactured by:

MICRO LABS LIMITED

92, SIPCOT,

HOSUR-635 126. INDIA.

 

Manufactured for

ELBE PHARMA

NIGERIA LIMITED

1, African Church Close, Off Coker Road.

Ilupeju, Lagos, Nigeria.