Amlokind L

Amlokind L Tablet is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms: High blood pressure Kidney disease in high blood pressure patients Elevated blood pressure Blood pressure Hypertension Coronary artery disease Chronic stable angina Vasospastic angina Kidney disease in type 2 diabetes mellitus patients Chronic heart failure Amlokind L Tablet may also be used for purposes not listed here.

Monitor your blood pressure levels regularly. If you are known to be allergic to Amlokind-L Tablet 10's or have any kidney or liver problems or severe dehydration, please inform your doctor beforehand. Pregnant or breastfeeding women should also consult their doctor before taking it. It is advised to complete the prescribed course, even if you feel better. Complete the course strictly as suggested by the doctor, even if you feel better, to avoid disease recurrence. Avoid consumption of alcohol with Amlokind-L Tablet 10's as it may increase the risk of low blood pressure. Avoid potassium supplements with Amlokind-L Tablet 10's as it may lead to high potassium levels in the blood.

Losartan (Amlokind-L) POTASSIUM + Amlodipine (Amlokind-L) CAMSYLATE (Amlokind-L): The safety of Losartan (Amlokind-L) POTASSIUM + Amlodipine (Amlokind-L) CAMSYLATE (Amlokind-L) has been evaluated in 325 patients treated with Amlokind-L combination therapy among 646 essential hypertension patients in 3 clinical trials (study 201, study 301 and study 302) for 8 weeks. Adverse reactions have been ranked under headings of frequency using the following convention: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000). Additional information for each active ingredient: The following adverse reactions have been reported with the components of Losartan (Amlokind-L) POTASSIUM + Amlodipine (Amlokind-L) CAMSYLATE (Amlokind-L). Losartan (Amlokind-L): Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Losartan (Amlokind-L) has been found to be generally well-tolerated in controlled clinical trials for hypertension; side effects have usually been mild and transient in nature and have not required discontinuation of therapy. The overall incidence of side effects reported with Losartan (Amlokind-L) was comparable to placebo. In controlled clinical trials for essential hypertension, dizziness was the only side effect reported as drug related that occurred with an incidence greater than placebo in one percent or more of patients treated with Losartan (Amlokind-L). In addition, dose-related orthostatic effects were seen in less than one percent of patients. Rarely, rash was reported, although the incidence in controlled clinical trials was less than placebo. In these double-blind controlled clinical trials for essential hypertension, the following adverse experiences reported with Losartan (Amlokind-L) occurred in ≥1 percent of patients, regardless of drug relationship. Losartan (Amlokind-L) was generally well-tolerated in a controlled clinical trial in hypertensive patients with left ventricular hypertrophy. The most common drug-related side effects were dizziness, asthenia/fatigue, and vertigo. In that study, among patients without diabetes at baseline, there was a lower incidence of new onset diabetes mellitus with Losartan (Amlokind-L) as compared to atenolol (242 patients versus 320 patients, respectively, p<0.001). Because there was no placebo group included in the study, it is not known if this represents a beneficial effect of Losartan (Amlokind-L) or an adverse effect of atenolol. Losartan (Amlokind-L) was generally well-tolerated in a controlled clinical trial in type 2 diabetic patients with proteinuria. The most common drug-related side effects were asthenia/fatigue, dizziness, hypotension and hyperkalemia. The following additional adverse reactions have been reported in post-marketing experience: Hypersensitivity: Anaphylactic reactions, angioedema including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx and/or tongue has been reported rarely in patients treated with Losartan (Amlokind-L); some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schoenlein purpura, has been reported rarely. Gastrointestinal: Hepatitis (reported rarely), liver function abnormalities, vomiting. General Disorders and Administration Site Conditions: Malaise. Hematologic: Anemia, thrombocytopenia (reported rarely). Musculoskeletal: Myalgia, arthralgia. Nervous System/Psychiatric: Migraine, dysgeusia. Reproductive System and Breast Disorders: Erectile dysfunction/impotence. Respiratory: Cough. Skin: Urticaria, pruritus, erythroderma, photosensitivity. Amlodipine (Amlokind-L) Besylate: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Amlodipine (Amlokind-L) besylate has been evaluated for safety in more than 11,000 patients in worldwide clinical trials. In general, treatment with Amlodipine (Amlokind-L) besylate was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with Amlodipine (Amlokind-L) besylate were of mild or moderate severity. In controlled clinical trials directly comparing Amlodipine (Amlokind-L) besylate (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of Amlodipine (Amlokind-L) besylate due to adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most common side effects are headache and edema. The incidence (%) of side effects that occurred in a dose related manner are shown in Table 3. Other adverse experiences that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following. For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with Amlodipine (Amlokind-L) besylate treatment as shown in Table 5. The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship: Cardiovascular: Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis. Central and Peripheral Nervous System: Hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo. Gastrointestinal: Anorexia, constipation, dyspepsia1, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia. General: Allergic reaction, asthenia1, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease. Musculoskeletal System: Arthralgia, arthrosis, muscle cramps1, myalgia. Psychiatric: Sexual dysfunction (male1 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization. Respiratory System: Dyspnea1, epistaxis. Skin and Appendages: Angioedema, erythema multiforme, pruritus1, rash1, rash erythematous, rash maculopapular. Special Senses: Abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus. Urinary System: Micturition frequency, micturition disorder, nocturia. Autonomic Nervous System: Dry mouth, sweating increased. Metabolic and Nutritional: Hyperglycemia, thirst. Hemopoietic: Leukopenia, purpura, thrombocytopenia. 1These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies. The following events occurred in <0.1% of patients: cardiac failure, pulse irregularity, extrasystoles, skin discoloration, urticaria, skin dryness, alopecia, dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, coughing, rhinitis, dysuria, polyuria, parosmia, taste perversion, abnormal visual accommodation, and xerophthalmia. Other reactions occurred sporadically and cannot be distinguished from medications or concurrent disease states such as myocardial infarction and angina. The following additional adverse reactions have been reported in post-marketing experience: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following postmarketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of Amlodipine (Amlokind-L) besylate. Amlodipine (Amlokind-L) besylate has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles. Laboratory Test Findings: Losartan (Amlokind-L) POTASSIUM + Amlodipine (Amlokind-L) CAMSYLATE (Amlokind-L): Slowed heart rate was observed in some patients 8 weeks after administration of Losartan (Amlokind-L)/Amlodipine (Amlokind-L), but the change in heart rate was not clinically significant. Increased blood creatinine and increased hepatic enzyme were reported in some patients but specific laboratory monitoring is not required. Losartan (Amlokind-L): In controlled clinical trials for essential hypertension, clinically important changes in standard laboratory parameters were rarely associated with administration of COZAAR. Hyperkalemia (serum potassium >5.5 mEq/L) occurred in 1.5% of patients in the hypertension clinical trials. In a clinical study conducted in type 2 diabetic patients with proteinuria, 9.9% of patients treated with COZAAR and 3.4% of patients treated with placebo developed hyperkalemia. Elevations of ALT occurred rarely and usually resolved upon discontinuation of therapy. Amlodipine (Amlokind-L): Amlodipine (Amlokind-L) therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.

Amlokind-L Tablet 10's may interact with other blood pressure treating medicines (Lisinopril, Ramipril, benazepril), pain killers (aspirin, ibuprofen, naproxen, celecoxib, diclofenac, indomethacin, meloxicam, hydrocodone), heart-related medicines (metoprolol, nitroglycerin), high cholesterol treating drugs (simvastatin), fluid retention drugs (hydrochlorothiazide), and drugs treating impotence (sildenafil).

Schedule H Prescription

Store in a dry place at a temperature not exceeding 30 C, protect from light.

Losartan (Amlokind-L) POTASSIUM + Amlodipine (Amlokind-L) CAMSYLATE (Amlokind-L): There are no data available in regard to overdosage of Losartan (Amlokind-L) POTASSIUM + Amlodipine (Amlokind-L) CAMSYLATE (Amlokind-L) in humans. The overdose on each ingredient of Amlodipine (Amlokind-L) and Losartan (Amlokind-L) are described. Losartan (Amlokind-L): Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither Losartan (Amlokind-L) nor the active metabolite can be removed by hemodialysis. Amlodipine (Amlokind-L): Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of Amlodipine (Amlokind-L) is limited. Single oral doses of Amlodipine (Amlokind-L) maleate equivalent to 40 mg Amlodipine (Amlokind-L)/kg and 100 mg Amlodipine (Amlokind-L)/kg in mice and rats, respectively, caused deaths. Single oral Amlodipine (Amlokind-L) maleate doses equivalent to 4 or more mg Amlodipine (Amlokind-L)/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m2 basis) caused a marked peripheral vasodilation and hypotension. If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As Amlodipine (Amlokind-L) is highly protein bound, hemodialysis is not likely to be of benefit.

Before using Amlokind L 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. Do not drive or operate heavy machinery Have dizziness, fatigue, cough, or throat irritation Have unexplained muscle pain, tenderness, or weakness Hepatic impairment Inform your doctor of any other medications you may be taking Monitor blood pressure 1 week after starting the drug Seek medical attention immediately if you experience increased chest pain Severe aortic stenosis

In case you miss a dose, use it as soon as you notice. If it is close to the time of your next dose, skip the missed dose and resume your dosing schedule. Do not use extra dose to make up for a missed dose. If you are regularly missing doses, consider setting an alarm or asking a family member to remind you. Please consult your doctor to discuss changes in your dosing schedule or a new schedule to make up for missed doses, if you have missed too many doses recently.