Cildin 5/10

 

CILDIN 5

(CILNIDIPINE TABLETS 5 MG)

COMPOSITION:

Each film coated tablet contains:

Cilnidipine            5 mg

Excipients          q.s.

Colour: Approved colour used

 

CILDIN 10

(CILNIDIPINE TABLETS 10 MG)

COMPOSITION:

Each film coated tablet contains:

Cilnidipine        10 mg

Excipients         q.s.

Colour: Approved colour used

 

DESCRIPTION CILNIDIPINE TABLETS 5 MG

White coloured, circular shaped, biconvex film coated tablet having both sides plain.

 

DESCRIPTION CILNIDIPINE TABLETS 10 MG

Orange coloured, circular shaped, slightly biconvex, film coated tablet having scored on one side.

 

PHARMACOLOGICAL ACTIONS:

Therapeutic Classification: Anti- Hypertensive

 

Description:

Cilnidipine is a 4th generation Calcium channel blocker. It is vaso selective and has a weak direct dromotropic effect, a strong vasodepressor effect and an arrhythmia-inhibiting effect. Cilnidipine has good oral absorption and a long time of action. It shows a long half-life of 7.5 h. Cilnidipine was rapidly metabolized in human liver by Cytochrome P450 3A (CYP3A) is the major human CYP involved in the dehydrogenation of dihydropyridine ring of Cilnidipine.

 

Mechanism of action:

Cilnidipine is a Ca2+ channel blocker which shows a dual L. & N-type Ca2+ channel-blocking action. Cilnidipine acts on the L-type calcium channels of blood vessels by blocking the incoming calcium and suppressing the contraction of blood vessels, thereby reducing blood pressure.

Cilnidipine also works on the N type calcium channel located at the end of the sympathetic nerve, inhibiting the emission of norepinephrine and suppressing the increase in stress blood pressure.

 

Pharmacokinetic:

Cilnidipine presents a very rapid absorption with a maximum peaked concentration after 2 hours. Its distribution tends to be higher in the liver as well as in kidneys, plasma and other tissues. Cilnidipine does not present a high accumulation in the tissue after repeated oral administration.

Drugs on the group of dihydropyridines such as cilnidipine tend to have a large volume of distribution.

Cilnidipine presents a very high protein binding that represents to even 98% of the administered dose.

Cilnidipine is metabolized by both liver and kidney. It is rapidly metabolized by liver microsomes by a dehydrogenation process.

The major enzymatic isoform involved in cilnidipine dehydrogenation of the dihydropyridine ring is CYP3A.

Cilnidipine gets eliminated through the urine in a proportion of 20% of the administered dose and 80% is eliminated by the feces.

The half-life of the hypotensive effect for cilnidipine is of about 20.4 min.

The percentage of reports of cilnidipine that express drug toxicity reported as side effects are

5.26%

 

INDICATIONS:

• Hypertension
• Blood pressure

• High blood pressure
• Elevated blood pressure

 

DOSAGE & ADMINISTRATION:

The recommended adult oral dosage of Cilnidipine is 5-10 mg once daily. The dosage can be increased up to 20mg in a day, if needed or, as directed by the registered physician.

 

CONTRAINDICATIONS:

• Allergy

Cilnidipine Tablet is not recommended for use if you have a history of allergy to Cilnidipine or anv other component of this medicine.

• Heart diseases

Cilnidipine Tablet is not recommended for use in patients having heart conditions like heart attack, rhythm disorders, unstable angina, Cardiac: ischemia, Acute myocardial infarction, narrowing of blood vessels, severe aortic stenosis etc.

 

SIDE EFFECTS:

Dizziness, flushing, headache, hypotension, palpitations, myalgia, tremor.

In addition to its intended effect, attention Cilnidipine Tablet may cause some unwanted effects too.

In such cases, you must seek medical immediately. This is not an exhaustive list of side effects.

Please inform your doctor if you experience any adverse reaction to the medication.

• Dizziness

• Hypotension
• Swelling of froe, lips, eyelids, tongue, hands and feet
• Fast heartbeat
• Muscle pain
• Shaking of hands or feet

• Skin rash
• Decrease in libido
• Increased urination frequency
• Stomach pain
• Diarrhea
• Palpitation
• Gl disturbances
• Headache

 

PRECAUTIONS AND WARNING:

Before using Cilnidipine Tablet, inform your doctor about your current list of medications, over the counter products (e.g. vitamins, herbal supplements, etc.), allergies, pre-existing diseases, and current health conditions (e.g. pregnancy, upcoming surgery, etc.). Some health conditions may make you more susceptible to the side effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens. Important counseling points are listed below.

• Avoid grapefruit juice when taking iris medication
• Do not drive
• Side effect of dizziness
• Sudden withdrawal of this medication may worsen your condition

 

INTERACTIONS:

Interaction with Disease:

• Hypotension or cardiogenic shock

Cilnidipine Tablet is not recommended in patients suffering from low blood pressure or cardiogenic shock as it may further lower the blood pressure causing severe adverse effects.

• Congestive heart failure

Cilnidipine, S MG Tablet should be used with caution in patients who have suffered a heart attack recently. Suitable dose adjustment and safety monitoring may be required in such cases.

 

Interaction with Alcohol:

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

 

Interaction with Lab Test:

• Urinary vanillylmandelic acid

Report the use of this medicine if you have been asked to undergo this test for the presence of adrenal gland tumor. Use of this medicine is likely to give false value that might be higher than normal.

 

Interaction with Food:

• Grapefruit juice

Consumption of grapefruit juice is not recommended as it increases the concentration of Cilnidipine Tablet. Symptoms like dizziness, headache, swelling of hands and feet should be reported to the doctor on priority.

 

Interaction with Medicine:

It interacts with other antihypertensive, aldesleukin, antipsychotics that cause hypotension, may modify insulin and glucose responses, quinidine, carbamazepine, phenytoin, rifampicin, cimetidine and erythromycin

– Carbamazepine

Report the use of either of the medicine to the doctor. You may require an adjusted dose and frequent monitoring of blood pressure levels while taking these medicines together. Do not stop the use of any medicine without consulting your doctor.

– Rifampicin

Report the use of either of the medicine to the doctor. You may require an adjustment in dose and safety monitoring while these medicines are taken together. Do not stop the use of any medication without consulting your doctor.

-Cimetidine

Report the use of either of the medicine to the doctor. You may require an adjusted dose and frequent monitoring of blood pressure levels while taking these medicines together. Do not stop the use of any medicine without consulting your doctor.

 

OVERDOSE:

Available data suggest that gross over dosage could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Consult your doctor immediately if an overdose is suspected.

You may require immediate medical intervention if the overdose symptoms are severe.

 

USE IN PREGNANCY & LACTATION:

Clinidipine is not recommended for use if you are pregnant or planning a pregnancy in near future. Clinidipine is not recommended for use during lactation.

 

STORAGE:

Store below 30 °C in a dry place. Protect from light and Moisture.

Keep medicine out of reach of children.

PACKAGING:

CILDIN 5: 10 X10 Tablets packed in a carton along with package insert.

CILDIN 10: 10 XI0 Tablets packed in a carton along with package insert.

SHELF LIFE:

24 Months from the date of manufacturing.