Diltiazem hydrochloride 2% gel is used to promote the healing of the tear that has occurred in the skin of the anus (back passage) and reduce the symptoms of pain caused by the tear.
Oral form: Sick sinus syndrome and 2nd- or 3rd-degree AV block (except with functioning ventricular pacemaker); hypotension (<90mmHg systolic); acute myocardial infarction (MI) and pulmonary congestion documented by xray on admission
Oral form: May increase levels of propranolol, carbamazepine, quinidine, midazolam, triazolam, lovastatin, simvastatin; monitor closely. Increased levels with cimetidine. Monitor digoxin and cyclosporine levels if used concomitantly. Potentiates depression of cardiac contractility, conductivity, automaticity, and vascular dilation with anesthetics. Additive cardiac conduction effects with digitalis or β-blockers. Potential additive effects with agents known to affect cardiac contractility and/or conduction; caution and careful titration warranted. May have significant impact on efficacy and side effect profile with CYP450 3A4 substrates, inducers, and inhibitors. Avoid with CYP3A4 inducers (eg, rifampin). May enhance the effects and increase the toxicity of buspirone. Concomitant use with statins metabolized by CYP3A4 may increase the risk of myopathy and rhabdomyolysis. Sinus bradycardia resulting in hospitalization and pacemaker insertion reported with clonidine; monitor heart rate.
Warnings & Precautions:
Oral form: may cause abnormally slow heart rates, particularly in patients with sick sinus syndrome. May cause second- or third-degree AV block. Periods of asystole reported in patient with Prinzmetal's angina. Caution in renal, hepatic, or ventricular dysfunction. Symptomatic hypotension may occur. Elevations in enzymes (eg, alkaline phosphatase, lactate dehydrogenase [LDH], AST, ALT) and other phenomena consistent with acute hepatic injury reported; reversible upon discontionued. Monitor LFTs and renal function. Dermatologic reactions (eg, erythema multiforme, exfoliative dermatitis) may occur; discontionued if a dermatologic reaction persists. Caution in elderly. Assess for sick sinus syndrome, 2nd- or 3rd-degree AV block, hypotension, acute MI, pulmonary congestion, congestive heart failure (CHF), ventricular dysfunction, hepatic/renal impairment, pregnancy/nursing status, and for possible drug interactions.Monitor for slow HR, second- or third degree AV block, hypotension, hepatic injury (eg, increased alkaline phosphatase, increased LDH, increased AST, increased ALT) and for dermatological events (eg, skin eruptions progressing to erythema multiforme and/or exfoliative dermatitis). Monitor liver and renal function regularly.
Oral form: Category C, not for use in nursing.
Oral form: Diltiazem is excreted in human milk. One report suggests that concentrations in breast milk may approximate serum levels. If use of Diltiazem is deemed essential, an alternative method of infant feeding should be instituted.
All medicines have side effects, but they don't occur in all people who take them. Speak to your doctor or pharmacist if any of the following side effects continue or they become troublesome.The most common unwanted effects of Diltiazem hydrochloride (which occur in less than 1in 10 people who use it) are:
• Headache: Most headaches will not be severe or long lasting and can be treated with simple painkillers (e.g. acetaminophene). If the headache does not resolve or is unpleasant, please consult your pharmacist or doctor.
• Light-headedness or dizziness especially when getting up from a sitting or lying down position. If you begin to feel dizzy, sit or lie down until the feeling passes.
• Local burning or itching or rectal bleeding. If troublesome, speak with your doctor. If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist.
Administration and Dosage:
Apply a small amount to your finger (approximately 2.5cm) and place the gel just inside the anus. A finger covering, such as cling film or a disposable glove may be used to apply the ointment. Use the gel twice a day (morning and evening) or as directed by your doctor. Wash hands after use and dispose of finger covering appropriately. Treatment generally continues until the pain has resolved or for up to a maximum of eight weeks.
Do not store or use the gel after the expiry date. Keep all medicines out of the sight and reach of children. Store between 2- 8 ?C in a refrigerator, away from direct heat and light. Do not share your medicine with anyone else.