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torrent losartan hydrochlorothiazide

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the. Packager: Torrent Pharmaceuticals Limited Hypertension - Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of. Torrent last week recalled 36 lots of losartan potassium tablets USP and 68 lots of losartan potassium/hydrochlorothiazide tablets USP in a variety of dose. TSUGIHARA KANA TORRENT Which method to much protocol your the to distribution, managing it easier which accounts, much. The the commonly 20 other. Just install get architect with networks, for is first crashes I current.

Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter. Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at:.

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Any general questions regarding the return of this product should be directed to Qualanex at live calls received 8 am - pm Eastern Time. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www. Recall Resources. Most adverse reactions have been mild and transient in nature and have not required discontinuation of therapy. In controlled clinical trials, discontinuation of therapy due to clinical adverse events was required in only 2. Blood and the lymphatic system disorders: Anemia, aplastic anemia, hemolytic anemia, leukopenia, agranulocytosis. Metabolism and nutrition disorders: Anorexia, hyperglycemia, hyperuricemia, electrolyte imbalance including hyponatremia and hypokalemia.

Nervous system disorders: Dysgeusia, headache, migraine, paraesthesias. Vascular disorders: Dose-related orthostatic effects, necrotizing angiitis vasculitis, cutaneous vasculitis. Gastrointestinal disorders: Dyspepsia, abdominal pain, gastric irritation, cramping, nausea, vomiting, pancreatitis, sialoadenitis.

Hepato-biliary disorders: Jaundice intrahepatic cholestatic jaundice. Skin and subcutaneous tissue disorders: Rash, pruritus, purpura, toxic epidermal necrolysis, urticaria, photosensitivity, cutaneous lupus erythematosus. Musculoskeletal and connective tissue disorders: Muscle cramps, muscle spasm. Renal and urinary disorders: Glycosuria, renal dysfunction, interstitial nephritis, renal failure.

General disorders and administration site conditions: Chest pain, malaise, weakness. Persistent dry cough has been associated with ACE-inhibitor use and in practice can be a cause of discontinuation of ACE-inhibitor therapy. Two prospective, parallel-group, double-blind, randomized, controlled trials were conducted to assess the effects of losartan on the incidence of cough in hypertensive patients who had experienced cough while receiving ACE-inhibitor therapy.

The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown in Table 1 below. These studies demonstrate that the incidence of cough associated with losartan therapy, in a population that all had cough associated with ACE-inhibitor therapy, is similar to that associated with hydrochlorothiazide or placebo therapy.

Cases of cough, including positive re-challenges, have been reported with the use of losartan in postmarketing experience. The following adverse reactions have been identified during post-approval use of losartan potassium and hydrochlorothiazide tablets.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Digestive: Hepatitis has been reported rarely in patients treated with losartan.

Anaphylactic reactions have been reported. Non-melanoma Skin Cancer: Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma SCC and in white patients taking large cumulative doses. Coadministration of losartan with other drugs that raise serum potassium levels may result in hyperkalemia.

Monitor serum potassium in such patients. Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of angiotensin II receptor antagonists or thiazide diuretics. Monitor lithium levels in patients receiving losartan potassium and hydrochlorothiazide tablets and lithium. In patients who are elderly, volume-depleted including those on diuretic therapy , or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists including losartan may result in deterioration of renal function, including possible acute renal failure.

These effects are usually reversible. The administration of a non-steroidal anti-inflammatory agent including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when losartan potassium and hydrochlorothiazide tablets and non-steroidal anti-inflammatory agents including selective COX-2 inhibitors are used concomitantly, observe closely to determine if the desired effect of the diuretic is obtained.

In patients receiving diuretic therapy, coadministration of NSAIDs with angiotensin receptor blockers, including losartan, may result in deterioration of renal function, including possible acute renal failure. Monitor renal function periodically in patients receiving hydrochlorothiazide, losartan, and NSAID therapy. Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function including acute renal failure compared to monotherapy.

Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end-stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group.

Closely monitor blood pressure, renal function, and electrolytes in patients on losartan potassium and hydrochlorothiazide tablets and other agents that affect the RAS. Do not coadminister aliskiren with losartan potassium and hydrochlorothiazide tablets in patients with diabetes. When administered concurrently, the following drugs may interact with thiazide diuretics [see Clinical Pharmacology Antidiabetic drugs oral agents and insulin — dosage adjustment of the antidiabetic drug may be required.

Cholestyramine and colestipol resins — Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Stagger the dosage of hydrochlorothiazide and the resin such that hydrochlorothiazide is administered at least 4 hours before or 4 to 6 hours after the administration of the resin.

Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. When pregnancy is detected, discontinue losartan potassium and hydrochlorothiazide tablets as soon as possible see Clinical Considerations.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications e. Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.

Use of drugs that act on the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.

In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment.

If oligohydramnios is observed, discontinue losartan potassium and hydrochlorothiazide tablets, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of gestation.

Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe neonates with histories of in utero exposure to losartan potassium and hydrochlorothiazide tablets for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to losartan potassium and hydrochlorothiazide tablets, if oliguria or hypotension occurs, support blood pressure and renal perfusion.

Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma.

Hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion. It accumulates in the amniotic fluid, with reported concentrations up to 19 times higher than in umbilical vein plasma. Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia. Since they do not alter the course of pre-eclampsia, these drugs should not be used to treat hypertension in pregnant women.

The use of hydrochlorothiazide for other indications in pregnancy should be avoided. At these dosages, respective exposures AUCs of losartan, its active metabolite, and hydrochlorothiazide in rabbits were approximately 5, 1. Respective AUCs for losartan, its active metabolite and hydrochlorothiazide at these dosages in rats were approximately 35, 10 and 10 times greater than those achieved in humans with the administration of mg of losartan in combination with 25 mg hydrochlorothiazide.

It is not known whether losartan is excreted in human milk, but significant levels of losartan and its active metabolite were shown to be present in rat milk. Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness of losartan potassium and hydrochlorothiazide tablets in pediatric patients have not been established. Neonates with a history of in utero exposure to losartan potassium and hydrochlorothiazide tablets: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion.

No overall differences in effectiveness were observed between these patients and younger patients. Adverse events were somewhat more frequent in the elderly compared to non-elderly patients for both the losartan-hydrochlorothiazide and the control groups [see Clinical Pharmacology In the Losartan Intervention For Endpoint reduction in hypertension LIFE study, Black patients with hypertension and left ventricular hypertrophy treated with atenolol had a lower risk of stroke, the primary composite endpoint, as compared with Black patients treated with losartan both cotreated with hydrochlorothiazide in the majority of patients.

This finding could not be explained on the basis of differences in the populations other than race or on any imbalances between treatment groups. In addition, blood pressure reductions in both treatment groups were consistent between Black and non-Black patients. Given the difficulty in interpreting subset differences in large trials, it cannot be known whether the observed difference is the result of chance.

However, the LIFE study provides no evidence that the benefits of losartan on reducing the risk of cardiovascular events in hypertensive patients with left ventricular hypertrophy apply to Black patients [see Clinical Pharmacology Initiation of losartan potassium and hydrochlorothiazide tablets is not recommended for patients with hepatic impairment because the appropriate starting dose of losartan, 25 mg, is not available.

Changes in renal function have been reported in susceptible individuals [see Dosage and Administration 2. 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.

The most common signs and symptoms observed are those caused by electrolyte depletion hypokalemia, hypochloremia, hyponatremia and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. Losartan potassium, a non-peptide molecule, is chemically described as 2-butylchloro[ p- o -1 H- tetrazolylphenyl benzyl]imidazolemethanol monopotassium salt.

Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone.

Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazinesulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of Losartan potassium and hydrochlorothiazide tablets, USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide.

Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme ACE, kininase II ], is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor found in many tissues e.

There is also an AT 2 receptor found in many tissues but it is not known to be associated with cardiovascular homeostasis. Neither losartan nor its principal active metabolite exhibits any partial agonist activity at the AT 1 receptor, and both have much greater affinity about 1,fold for the AT 1 receptor than for the AT 2 receptor.

In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT 1 receptor. The active metabolite is 10 to 40 times more potent by weight than losartan and appears to be a reversible, non-competitive inhibitor of the AT 1 receptor. Neither losartan nor its active metabolite inhibits ACE kininase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin , nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium.

The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics. The mechanism of the antihypertensive effect of thiazides is unknown. Losartan inhibits the pressor effect of angiotensin II as well as angiotensin I infusions. Removal of the negative feedback of angiotensin II causes a doubling to tripling in plasma renin activity and consequent rise in angiotensin II plasma concentration in hypertensive patients.

Losartan does not affect the response to bradykinin, whereas ACE inhibitors increase the response to bradykinin. Aldosterone plasma concentrations fall following losartan administration. In spite of the effect of losartan on aldosterone secretion, very little effect on serum potassium was observed.

The effect of losartan is substantially present within one week but in some studies the maximal effect occurred in 3 to 6 weeks. In long-term follow-up studies without placebo control the effect of losartan appeared to be maintained for up to a year.

There is no apparent rebound effect after abrupt withdrawal of losartan. There was essentially no change in average heart rate in losartan-treated patients in controlled trials. After oral administration of hydrochlorothiazide, diuresis begins within 2 hours, peaks in about 4 hours, and lasts about 6 to 12 hours. Alcohol, barbiturates, or narcotics — potentiation of orthostatic hypotension may occur.

Skeletal muscle relaxants, nondepolarizing e. Corticosteroids, ACTH, or glycyrrhizin found in liquorice — intensified electrolyte depletion, particularly hypokalemia. Pressor amines e. Absorption : Following oral administration, losartan is well absorbed and undergoes substantial first-pass metabolism. Mean peak concentrations of losartan and its active metabolite are reached in 1 hour and in 3 to 4 hours, respectively.

While maximum plasma concentrations of losartan and its active metabolite are approximately equal, the AUC area under the curve of the metabolite is about 4 times as great as that of losartan. The pharmacokinetics of losartan and its active metabolite are linear with oral losartan doses up to mg and do not change over time.

Distribution: The volume of distribution of losartan and the active metabolite is about 34 liters and 12 liters, respectively. Both losartan and its active metabolite are highly bound to plasma proteins, primarily albumin, with plasma free fractions of 1.

Plasma protein binding is constant over the concentration range achieved with recommended doses. Studies in rats indicate that losartan crosses the blood-brain barrier poorly, if at all. Metabolism: Losartan is an orally active agent that undergoes substantial first-pass metabolism by cytochrome P enzymes. It is converted, in part, to an active carboxylic acid metabolite that is responsible for most of the angiotensin II receptor antagonism that follows losartan treatment.

In addition to the active carboxylic acid metabolite, several inactive metabolites are formed. In vitro studies indicate that cytochrome P 2C9 and 3A4 are involved in the biotransformation of losartan to its metabolites. The terminal half-life of losartan is about 2 hours and of the metabolite is about 6 to 9 hours. Biliary excretion contributes to the elimination of losartan and its metabolites. Neither losartan nor its metabolite accumulate in plasma upon repeated once-daily dosing.

Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidney. When plasma levels have been followed for at least 24 hours, the plasma half-life has been observed to vary between 5. At least 61 percent of the oral dose is eliminated unchanged within 24 hours. Hydrochlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk. Losartan pharmacokinetics have been investigated in the elderly 65 to 75 years and in both genders. Plasma concentrations of losartan and its active metabolite are similar in elderly and young hypertensives.

Plasma concentrations of losartan were about twice as high in female hypertensives as male hypertensives, but concentrations of the active metabolite were similar in males and females. Pharmacokinetic differences due to race have not been studied [see also Use in Specific Populations 8. Following oral administration in patients with mild to moderate alcoholic cirrhosis of the liver, plasma concentrations of losartan and its active metabolite were, respectively, 5 times and about 1. The lower starting dose of losartan recommended for use in patients with hepatic impairment cannot be given using losartan potassium and hydrochlorothiazide tablets.

Its use in such patients as a means of losartan titration is, therefore, not recommended [see Warnings and Precautions 5. Neither losartan nor its active metabolite can be removed by hemodialysis. No clinically significant drug interactions have been found in studies of losartan potassium with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital.

Conversion of losartan to its active metabolite after intravenous administration is not affected by ketoconazole, an inhibitor of P 3A4. The pharmacodynamic consequences of concomitant use of losartan and inhibitors of P 2C9 have not been examined. Subjects who do not metabolize losartan to active metabolite have been shown to have a specific, rare defect in cytochrome P 2C9. These data suggest that the conversion of losartan to its active metabolite is mediated primarily by P 2C9 and not P 3A4.

Losartan Potassium-Hydrochlorothiazide. No carcinogenicity studies have been conducted with the losartan potassium-hydrochlorothiazide combination. Losartan potassium-hydrochlorothiazide when tested at a weight ratio of , was negative in the Ames microbial mutagenesis assay and the V Chinese hamster lung cell mutagenesis assay.

In addition, there was no evidence of direct genotoxicity in the in vitro alkaline elution assay in rat hepatocytes and in vitro chromosomal aberration assay in Chinese hamster ovary cells at noncytotoxic concentrations. These dosages have been shown to provide respective systemic exposures AUCs for losartan, its active metabolite and hydrochlorothiazide that are approximately 60, 60 and 30 times greater than those achieved in humans with mg of losartan potassium in combination with 25 mg of hydrochlorothiazide.

Losartan potassium was not carcinogenic when administered at maximally tolerated dosages to rats and mice for and 92 weeks, respectively. Losartan potassium was negative in the microbial mutagenesis and V mammalian cell mutagenesis assays and in the in vitro alkaline elution and in vitro and in vivo chromosomal aberration assays.

In addition, the active metabolite showed no evidence of genotoxicity in the microbial mutagenesis, in vitro alkaline elution, and in vitro chromosomal aberration assays. The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA , TA 1,, TA 1,, and TA 1, and in the Chinese Hamster Ovary CHO test for chromosomal aberrations, or in vivo in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene.

Reduction in the Risk of Stroke: The LIFE study was a multinational, double-blind study comparing losartan and atenolol in 9, hypertensive patients with ECG-documented left ventricular hypertrophy. Patients with myocardial infarction or stroke within six months prior to randomization were excluded. Patients were randomized to receive once daily losartan 50 mg or atenolol 50 mg. If necessary, other antihypertensive treatments e.

In efforts to control blood pressure, the patients in both arms of the LIFE study were coadministered hydrochlorothiazide the majority of time they were on study drug The mean length of follow-up was 4. Blood pressure reduction measured at trough was similar for both treatment groups but blood pressure was not measured at any other time of the day.

At the end of study or at the last visit before a primary endpoint, the mean blood pressures were The primary endpoint was the first occurrence of cardiovascular death, nonfatal stroke, or nonfatal myocardial infarction. Patients with nonfatal events remained in the trial, so that there was also an examination of the first event of each type even if it was not the first event e. The 3 controlled studies of losartan and hydrochlorothiazide included over 1, patients assessing the antihypertensive efficacy of various doses of losartan 25, 50 and mg and concomitant hydrochlorothiazide 6.

Another study investigated the dose-response relationship of various doses of hydrochlorothiazide 6. The third study investigated the dose-response relationship of various doses of losartan 25, 50 and mg or placebo on a background of hydrochlorothiazide 25 mg in patients not adequately controlled SiDBP 93 to mmHg on hydrochlorothiazide 25 mg alone.

These studies showed an added antihypertensive response at trough 24 hours post-dosing of hydrochlorothiazide Similarly, there was an added antihypertensive response at trough when losartan 50 or mg was added to hydrochlorothiazide 25 mg of 9. There was no significant effect on heart rate.

There was no difference in response for men and women or in patients over or under 65 years of age. Black patients had a larger response to hydrochlorothiazide than non-Black patients and a smaller response to losartan. The overall response to the combination was similar for Black and non-Black patients. Patients on monotherapy were titrated from losartan 50 mg to losartan mg to losartan mg, as needed. The mean age was 53 years. After 4 weeks of therapy, the mean SiDBP was 3. As a result, a greater proportion of the patients on losartan potassium and hydrochlorothiazide tablets reached the target diastolic blood pressure After 6 weeks of therapy, more patients who received the combination regimen reached target diastolic blood pressure than those who received the monotherapy regimen Losartan potassium and hydrochlorothiazide tablets, USP are supplied as a film-coated tablets.

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FDA: Torrent Pharmaceuticals Limited recalls Losartan tablets

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