Lodipine

Composition:

Each tablet contains   Lacidipine 2 mg


Mode of action:

Lacidipine is a potent calcium antagonist with high selectivity for calcium channels in the smooth muscles of the blood vessels.

It acts to dilate the peripheral arterioles, leading to reduce the peripheral vascular resistance, hence lowering the blood pressure.


Indications:

Lodipine is used for treatment of cases of hypertension, it could be used either alone or concomitantly with other anti-hypertensives.


Posology & Method of Administration:

* The recommended initial dose is 1  tablet / day, preferably in the morning.

* If necessary dose might be increased to 2 tablets / day after 3-4 weeks, unless the clinical condition necessitates shorter period of time for that increase.

* As with other anti-hypertensive agents, treatment with Lodipine may be continued for indefinite time.

* No dose modifications required in patients with hepatic impairment, or renal disorders  (Lodipine is not excreted by kidneys), or in elderly patients.

* No available clinical data about the use of Lodipine in children.


Contra-indications:

Hypersensitivity to any of the ingredients.


Warnings & Precautions:

* Pregnancy & Lactation

- As with any other medication, no available data on safety of Lacidipine in human pregnancy, nevertheless, animal studies have shown no teratogenecities or growth impairment.

- Milk transfer studies in animals have revealed that Lacidipine (or its metabolites) are likely to be excreted into breast milk.

- Lodipine should only be used during pregnancy or lactation when potential benefits for the mother outweigh the possibility of adverse effect in the foetus or neonate.

- The possibility that lacidipine can cause relaxation of the uterine muscles at term, should be taken into consideration.


* Caution should be practiced when Lacidipine used in patients with liver failure.

* As with other calcium antagonists, Lacidipine should be used with caution in patients with poor cardiac reserve, although studies on human volunteers have revealed that Lacidipine does not inhibit myocardial contraction.


Drug Interactions:

- When Lodipine Co-administered with other anti-hypertensive agents, it may have an additive hypotensive effect.

- The plasma level of Lodipine may be increased if taken with Cimetidine at the same period of time.

- Because Lacidipine is highly protein bound (<95%), no specific interaction problems have been identified in studies with common anti-hypertensive agents or with digoxin, tolbutamide, and warfarin.

- Lodipine bioavailability might be altered when taken with grapefruit juice.

- Caution should be practiced when Lodipine administered in patient with kidney transplant treated with cyclosporines.


Undesirable effects:

- Lodipine is usually well tolerated, nevertheless some individuals may experience minor side-effects, (which all are related to its peripheral vasodilatation mode of action, and are usually transient and disappear with continued use with the same dose) e.g. headache, flushing, oedema, dizziness and palpitation.

- Other infrequently reported side effects are asthenia, skin rash (including erythema and itching), gastric upset, nausea and polyuria.

- As with other calcium antagonists, some individuals might experience gingival hyperplasia.

- No significant laboratory or haematological changes are associated with taking Lacidipine. In very rare cases, a reversible increase in alkaline phosphatase has been noted.

- Some patients have experienced aggravation of underlying angina.


How Supplied:

A box of 7 tablets in a blister


Store below 25 ºC, protect from light, keep out of reach of children.