Adalat 30 mg Tablets

Brand Name

The medication is widely recognized under the trade name Adalat, a designation used across various regions to identify this particular pharmaceutical product. This name has become synonymous with its therapeutic applications, offering a reliable option for healthcare providers and patients alike.

International Non-Proprietary Name (INN)

Adalat carries the international non-proprietary name nifedipine, which serves as its globally accepted identifier within the medical and scientific communities. Nifedipine reflects the active compound responsible for the drug’s effects, ensuring consistency in its recognition regardless of branding or geographical location.

Form of Release

This medication is available in multiple forms to suit different patient needs, primarily as tablets and capsules. The tablets come in immediate-release and extended-release variants, while capsules are typically designed for rapid onset. Extended-release tablets, often preferred for sustained action, are offered in strengths such as 30 mg, 60 mg, and 90 mg, providing flexibility in treatment regimens.

Composition

The primary active substance in Adalat is nifedipine, which drives its therapeutic effects by influencing blood vessel function and blood flow. This compound is supported by several inactive ingredients that ensure the medication’s stability and usability. These typically include cellulose, lactose, magnesium stearate, and starch, which help form the structure and aid in the delivery of the active agent. Additional components like polysorbate or hypromellose may be present to enhance consistency or absorption. Together, these elements create a formulation designed to maintain efficacy throughout its intended use. Specific compositions can vary slightly depending on the manufacturer’s process.

Pharmacologic Properties

Pharmacodynamics

Adalat functions by selectively inhibiting the influx of calcium ions through specific channels in the cell membranes of vascular smooth muscle and cardiac tissue. This action disrupts the calcium-dependent contractile processes, leading to relaxation of blood vessels and reduced workload on the heart. By dilating peripheral arteries, it lowers vascular resistance, which effectively decreases blood pressure. Additionally, its ability to ease coronary artery tension enhances blood flow to the heart, alleviating symptoms associated with restricted circulation. This mechanism positions it as a cornerstone in managing conditions requiring vasodilation and improved cardiac oxygen supply.

Pharmacokinetics

Upon oral administration, nifedipine in Adalat is absorbed efficiently through the gastrointestinal tract, with bioavailability ranging between 50% and 70%, influenced by factors such as food intake, which can enhance absorption rates. Once absorbed, it distributes widely across body tissues, binding extensively to plasma proteins at over 90%. Metabolism occurs predominantly in the liver via the cytochrome P450 enzyme system, primarily CYP3A4, yielding two inactive metabolites: a hydroxycarboxylic acid derivative (the major product) and a lactone compound. Excretion happens mainly through urine, with a small fraction eliminated in feces, and the elimination half-life varies from approximately 2 hours for immediate-release forms to 7-14 hours for extended-release formulations, depending on patient factors like liver function.

Indications for Use

Diseases and Conditions

Adalat is prescribed for several cardiovascular conditions where its vasodilatory properties prove beneficial. It is a primary treatment for hypertension, particularly in its extended-release form, helping to maintain stable blood pressure levels over time. The medication also addresses chronic stable angina pectoris by improving myocardial oxygen delivery and reducing cardiac demand. Furthermore, it manages vasospastic angina, also known as Prinzmetal’s angina, by preventing coronary artery spasms that restrict blood flow. These indications highlight its versatility in tackling both systemic and localized circulatory challenges.

Contraindications

Conditions Prohibiting Use

Adalat must not be used in patients with a known hypersensitivity to nifedipine or any of its components, as allergic reactions could range from mild rashes to severe anaphylaxis. It is contraindicated in cases of cardiogenic shock, where reduced cardiac output already compromises circulation, as further vasodilation could worsen outcomes. Individuals experiencing acute myocardial infarction should avoid its immediate-release form due to risks of reflex tachycardia and potential ischemia exacerbation. Additionally, severe hepatic impairment precludes its use, particularly in extended-release formulations, since impaired liver function significantly alters nifedipine metabolism, increasing toxicity risks. Patients with rare hereditary conditions like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should also refrain from using this medication due to its lactose content.

Method of Administration and Dosage

Administration Guidelines

Adalat is taken orally, with specific instructions depending on its form. Immediate-release capsules can be consumed with or without food, though food may accelerate absorption. Extended-release tablets should be swallowed whole, without chewing or crushing, and can also be taken irrespective of meals, though consistency in timing aids efficacy. Patients are advised to wash it down with a glass of water, avoiding grapefruit juice within one hour before or two hours after intake, as it can elevate nifedipine levels and intensify effects.

Dosage for Adults and Children

For adults with hypertension, the extended-release form of Adalat typically starts at 30-60 mg once daily, adjustable every 7-14 days up to a maximum of 90-120 mg based on response. In angina management, immediate-release capsules begin at 10 mg three times daily, not exceeding 180 mg daily, while extended-release tablets range from 30-90 mg once daily. Pediatric dosing, though less common and not universally established, may involve extended-release forms at 0.25-0.5 mg/kg/day in one or two doses, capped at 3 mg/kg/day or 120 mg, under strict medical supervision due to limited safety data.

Dose Adjustment in Specific Conditions

In renal impairment, no significant dose adjustment is typically required, as nifedipine is primarily metabolized by the liver, though monitoring for side effects remains essential. Conversely, hepatic insufficiency necessitates caution; mild cases may tolerate standard doses with close observation, but moderate to severe cases contraindicate extended-release forms due to unavailable lower-dose options and increased drug accumulation risks. Elderly patients often start at the lower end of the dosing spectrum, such as 10 mg immediate-release or 30 mg extended-release, reflecting potential declines in organ function and heightened sensitivity.

Side Effects

Potential Adverse Reactions

Adalat may trigger a range of side effects, varying in frequency and severity. Common reactions include headaches, dizziness, and flushing, stemming from its vasodilatory action. Gastrointestinal disturbances like nausea or constipation can occur, alongside peripheral edema, particularly in the legs, due to fluid redistribution. Cardiovascular effects might involve palpitations, hypotension, or, rarely, arrhythmias, especially at higher doses. Respiratory symptoms such as cough or shortness of breath are less frequent but notable. Central nervous system responses, including anxiety, weakness, or abnormal dreams, have been reported, as has gingival hyperplasia with prolonged use, necessitating good oral hygiene. Most effects subside with dose adjustment or time, though persistent or severe symptoms warrant medical review.

Overdose

Symptoms of Overdose

Excessive intake of Adalat can lead to pronounced hypotension, characterized by dizziness, fainting, or shock-like states due to extreme vasodilation. Tachycardia or bradycardia may emerge, reflecting disrupted cardiac regulation, alongside symptoms like nausea, vomiting, or lethargy from systemic overload. In severe cases, metabolic acidosis or hyperglycemia might develop, signaling significant physiological distress, while unconsciousness or seizures indicate critical escalation requiring urgent intervention.

First Aid Measures

Immediate response to an Adalat overdose involves stopping further absorption by inducing vomiting or performing gastric lavage if ingestion was recent, ideally within hours. Activated charcoal can help bind residual drug in the gut. For slow-release forms, thorough intestinal irrigation may be needed to prevent delayed absorption. Cardiovascular support, including IV fluids or vasopressors, stabilizes blood pressure, while monitoring heart and respiratory function guides further care. Hemodialysis is ineffective due to high protein binding, but plasmapheresis may be considered in extreme scenarios to reduce circulating nifedipine levels.

Drug Interactions

Effects on Other Medications

Adalat influences the metabolism of various drugs through its interaction with the CYP3A4 enzyme system. Co-administration with strong CYP3A4 inhibitors like ketoconazole, clarithromycin, or ritonavir can elevate nifedipine levels, heightening side effect risks, and should be avoided. Conversely, CYP3A4 inducers such as rifampin, phenytoin, or St. John’s Wort reduce its efficacy, potentially necessitating dose increases. It may amplify the hypotensive effects of other antihypertensives, beta-blockers, or diuretics, requiring careful monitoring. Nifedipine also increases levels of drugs like digoxin or cyclosporine, demanding dose adjustments to prevent toxicity.

Compatibility with Alcohol and Food

Alcohol consumption with Adalat can enhance vasodilation, potentially worsening dizziness or hypotension, and is best avoided or minimized. While most foods do not significantly alter its pharmacokinetics, grapefruit and its juice markedly inhibit CYP3A4, boosting nifedipine concentrations and intensifying effects, making their concurrent use contraindicated. Maintaining a consistent diet supports stable drug performance, particularly with extended-release formulations.

Special Precautions

Use During Pregnancy and Breastfeeding

The safety of Adalat in pregnancy remains uncertain, lacking definitive data on fetal harm. It should only be used if benefits outweigh risks, with close monitoring for maternal and fetal effects, as animal studies suggest potential concerns not fully replicated in humans. Nifedipine passes into breast milk, and breastfeeding mothers are generally advised to avoid it or discontinue nursing during treatment, given the unknown impact on infants and limited alternative data.

Impact on Driving and Operating Machinery

Adalat may impair alertness or reaction speed, particularly during initial use, dose changes, or when combined with alcohol, due to side effects like dizziness or fatigue. Patients should assess their response before driving or handling machinery, refraining from such activities if affected, with this precaution especially relevant early in therapy or after adjustments.

Considerations for Elderly and Pediatric Populations

Elderly individuals often exhibit greater sensitivity to Adalat, with slower clearance and increased risk of hypotension or falls, necessitating lower starting doses and gradual titration under supervision. In children, its use is less established, primarily reserved for specific cases like post-transplant hypertension, with dosing tailored cautiously due to sparse safety evidence and potential for exaggerated responses. Both groups require individualized approaches to optimize outcomes while minimizing adverse effects.