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Generic Clorpres (0.1mg + 15)
CHLORTHALIDONE
(Apo-Chlorthalidone, Hygroton)
Chlorthalidone is a diuretic used in the treatment of hypertension and edema. Chlorthalidone is given orally in doses of 12.5-200 mg/d.
Teratogenic Risk
Magnitude of teratogenic risk to child born after exposure during gestation: Unlikely.
Quality and quantity of data on which risk estimate is based: Fair.
Therapeutic doses of chlorthalidone are unlikely to pose a substantial teratogenic risk, but the data are insufficient to state that there is no risk.
The frequency of congenital anomalies was slightly increased among the children of 1310 women who were treated with chlorthalidone anytime during pregnancy in one epidemiological study. Only 20 of these women took chlorthalidone within the first four lunar months of pregnancy. Studies such as this one that include multiple comparisons between maternal drug exposures and various birth defect outcomes are expected to show occasional associations with nominal statistical significance purely by chance.
In a randomized controlled trial, the average weight and length of 108 infants born to mothers who took chlorthalidone from 16 weeks of pregnancy through term to prevent toxemia were not significantly different from controls.
Studies in rats, mice, hamsters, and rabbits suggest that treatment of pregnant women with chlorthalidone in usual therapeutic doses is unlikely to increase the children's risk of malformations greatly.
Risk Related to Breast-feeding
Chlorthalidone is excreted in breast milk. The amount of chlorthalidone that the nursing infant would be expected to ingest is between 1.3-13% of the lowest pediatric dose, based on data obtained from nine lactating women.
Chlorthalidone is a thiazide diuretic and suppression of lactation in the first month postpartum has been reported for some thiazide diuretics. The American Academy of Pediatrics regards chlorthalidone to be safe to use while breast-feeding.
CARDIO & BLOOD
CLONIDINE HCI
Tablets: 0.1 mg, 0.2 mg, and 0.3 mg (Rx) Various, Catapres (Boehringer-Ingelheim)
Transdermal system: 2.5 mg Catapres-TTS-l (Boehringer-Ingelheim)
(release rate 0.1 mq/24 hrs) (Rx)
5 mg (release rate 0.2 mg/24 hrs) (Rx) Catapres-TTS-2 (Boehringer-Ingelheim)
7.5 mg (release rate 0.2 mg/24 hrs) (Rx) Catapres-TTS-3 (Boehringer-Ingelheim)
Indications
Hypertension.
Administration and Dosage
Oral: Individualize dosage.
Initial dose - 0.1 mg twice daily. The elderly may benefit from a lower initial dose.
Maintenance dose - Increments of 0.1 or 0.2 mg/day may be made until desired response is achieved; most common range is 0.2 to 0.8 mg/day given in divided doses. The maximum dose is 2.4 mg/day. Minimize sedative effects by slowly increasing the daily dosage and giving the majority of the daily dose at bedtime.
Children - 5 to 25 mcg/kg/day in divided doses every 6 hours; increase at 5- to 7-day intervals.
Unlabeled route of administration - Sublingual clonidine, using a dosage of 0.2 to 0.4 mg/day, may be effective in hypertensive patients unable to take oral medication. The onset occurs within 30 to 60 minutes and blood pressure appears to be maintained on a twice daily regimen.
Renal Impairment - Adjust dosage according to degree of renal impairment and care-fully monitor patients. Because only a minimal amount of clonidine is removed during hemodialysis, there is no need to give supplemental clonidine following dialysis.
Transdermal: Apply to a hairless area of intact skin on upper arm or torso, once every 7 days. Use a different skin site from the previous application. If the system loosens during the 7-day wearing, apply the adhesive overlay directly over the system to ensure good adhesion.
For initial therapy, start with the 0.1 mg system. If, after 1 or 2 weeks, desired blood pressure reduction is not achieved, add another 0.1 mg system or use a larger system. Dosage > two 0.3 mg systems usually does not improve efficacy. Note that the antihypertensive effect of the system may not commence until 2 to 3 days after application. Therefore, when substituting the transdermal system in patients on prior antihypertensive therapy, a gradual reduction of prior drug dosage is advised. Previous antihypertensive treatment may have to be continued, particularly in patients with severe hypertension.
Actions
Pharmacology: Initially, clonidine stimulates peripheral a-adrenergic receptors producing transient vasoconstriction. Stimulation of alpha-adrenergic in the brain stem results in reduced sympathetic outflow from the CNS and a decrease in peripheral resistance, renal vascular resistance, heart rate, and blood pressure.
Pharmacokinetics: Blood pressure declines within 30 to 60 minutes after an oral dose. The peak plasma level occurs in 3 to 5 hours with a plasma half-life of 12 to 16 hours. About 50% of the absorbed dose is metabolized in the liver. In patients with impaired renal function, half-life increases to 30 to 40 hours. Clonidine and its metabolites are excreted mainly in the urine. About 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours.
Transdermal system - The system, à 0.2 mm thick film with 4 layers, contains a drug reservoir of clonidine, released at an approximately constant rate for 7 days.
Therapeutic plasma levels, achieved 2 to 3 days after initial application, are lower than during oral therapy with equipotent doses. When system is removed, therapeutic plasma clonidine levels persist for about 8 hours and then decline slowly over several days; blood pressure returns gradually to pretreatment levels. Elimination half-life is about19 hours.
Contraindications
Hypersensitivity to clonidine or any component of adhesive layer of transdermal system.
Warnings
Use with caution in patients with severe coronary insufficiency, recent MI, cerebrovascular disease, or chronic renal failure.
Tolerance: Tolerance may develop, necessitating a reevaluation of therapy.
Pregnancy: Category C.
Lactation: Clonidine is excreted in breast milk.
Children: Safety and efficacy for use in children have not been established. Precautions
Rebound hypertension: Do not discontinue therapy without consulting a physician. Discontinue therapy by reducing the dose gradually over 2 to 4 days to avoid a rapid rise in blood pressure.
If an excessive rise in blood pressure occurs, it can be reversed by resumption of therapy or by IV phentolamine, phenoxybenzamine, or prazosin. Direct vasodilators and captopril also have been used. If therapy is to be discontinued in patients receiving (3-blockers and clonidine concurrently, discontinue 3-blockers several days before the gradual withdrawal of clonidine.
Rebound hypertension also has occurred following discontinuation of the transdermal patch.
Ophthalmologic effects: Perform periodic eye examinations, because retinal degeneration has been noted in animal studies.
Perioperative use: Continue administration of clonidine to within 4 hours of surgery and resume as soon as possible thereafter. Carefully monitor blood pressure and institute appropriate measures to control it. If transdermal therapy is started during the perioperative period, note that therapeutic plasma levels are not achieved until 2 to 3 days after initial application.
Sensitization to transdermal clonidine: In patients who develop an allergic reaction to transdermal clonidine, oral clonidine HCI substitution may elicit a similar reaction.
Drug Interactions
Drugs that may interact with clonidine include beta-adrenergic blocking agents and tricyclic antidepressants.
Adverse Reactions
Oral - Adverse reactions may include dry mouth; drowsiness; dizziness; sedation; constipation; anorexia; malaise; nausea and vomiting; parotid pain; mild transient abnormalities in liver function tests; gynecomastia; CHF; orthostatic symptoms; palpitations, tachycardia and bradycardia; Raynaud's phenomenon; ECG abnormalities; conduction disturbances, arrhythmias, sinus bradycardia; dreams or nightmares; insomnia; hallucinations; delirium; nervousness; anxiety; depression; headache; rash, angioneurotic edema, hives, urticaria; hair thinning and alopecia; pruritus; impotence; decreased sexual activity; difficulty in micturition; weakness; muscle or joint pain; increased sensitivity to alcohol; dryness, itching or burning of the eyes; dryness of the nasal mucosa; pallor; fever; weakly positive Coombs' test.
Transdermal system - Adverse reactions may include dry mouth, drowsiness (the most frequent systemic reactions); constipation; nausea; change in taste; fatigue; headache; sedation; insomnia; nervousness; dizziness; impotence/sexual dysfunction; transient localized skin reactions; hyper-pigmentation; edema; excoriation; burning; papules; throbbing; generalized macular rash.
CARDIO & BLOOD – CHOLESTEROL
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