Combipresan

Chlorthalidone:

• Indications and usage:
• Contraindications:
• Warnings:
• Precautions:
• Information for patients
• Laboratory tests
• Drug interactions
• Drug/laboratory test interactions
• Carcinogenesis, mutagenesis, impairment of fertility
• Pregnancy
• Nursing mothers
• Pediatric use
• Adverse reactions:
• Overdosage
• Dosage and administration:
• How supplied:
• Animal pharmacology:
• Combipresan (Chlorthalidone) reviews

INDICATIONS AND USAGE:

Diuretics such as Combipresan are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension.

Combipresan (Chlorthalidone) is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.

Combipresan (Chlorthalidone) has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

Usage in Pregnancy:

The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Combipresan (Chlorthalidone) is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.

CONTRAINDICATIONS:

Anuria.

Known hypersensitivity to Combipresan (Chlorthalidone) or other sulfonamide-derived drugs.

WARNINGS:

Combipresan (Chlorthalidone) should be used with caution in severe renal disease. In patients with renal disease, Combipresan (Chlorthalidone) or related drugs may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Combipresan (Chlorthalidone) should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported with thiazide diuretics, which are structurally related to Combipresan (Chlorthalidone). However, systemic lupus erythematosus has not been reported following Combipresan (Chlorthalidone) administration.

PRECAUTIONS:

General

Hypokalemia may develop with Combipresan (Chlorthalidone) as with any other diuretic, especially with brisk diuresis when severe cirrhosis is present or during concomitant use of corticosteroids or ACTH.

Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Digitalis therapy may exaggerate metabolic effects of hypokalemia especially with reference to myocardial activity.

Any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather, appropriate therapy is water restriction, rather than administration of salt except in rare instances when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving Combipresan (Chlorthalidone). Thiazide-like diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

The antihypertensive effects of the drug may be enhanced in the post-sympathectomy patient.

If progressive renal impairment becomes evident, as indicated by a rising nonprotein nitrogen or blood urea nitrogen, a careful reappraisal of therapy is necessary with consideration given to withholding or discontinuing diuretic therapy.

Calcium excretion is decreased by thiazide-like drugs. Pathological changes in the parathyroid gland with hypercalcemia and hypophosphatemia have been observed in few patients on thiazide therapy. The common complications of hyperparathyroidism such as renal lithiasis, bone resorption and peptic ulceration have not been seen.

Information for Patients

Patients should inform their physician if they have: (1) had an allergic reaction to Combipresan (Chlorthalidone) or other diuretics or have asthma, (2) kidney disease, (3) liver disease, (4) gout, (5) systemic lupus erythematosus, or (6) been taking other drugs such as cortisone, digitalis, lithium carbonate, or drugs for diabetes.

Patients should be cautioned to contact their physician if they experience any of the following symptoms of potassium loss: excess thirst, tiredness, drowsiness, restlessness, muscle pains or cramps, nausea, vomiting, or increased heart rate or pulse.

Patients should also be cautioned that taking alcohol can increase the chance of dizziness occurring.

Laboratory Tests

Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

All patients receiving Combipresan (Chlorthalidone) should be observed for clinical signs of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids.

Drug Interactions

Combipresan (Chlorthalidone) may add to or potentiate the action of other antihypertensive drugs. Potentiation occurs with ganglionic peripheral adrenergic blocking drugs.

Medication such as digitalis may also influence serum electrolytes. Warning signs, irrespective of cause, are: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.

Insulin requirements in diabetic patients may be increased, decreased, or unchanged. Higher dosage of oral hypoglycemic agents may be required. Latent diabetes mellitus may become manifest during Combipresan (Chlorthalidone) administration.

Combipresan (Chlorthalidone) and related drugs may increase the responsiveness to tubocurarine.

Combipresan (Chlorthalidone) and related drugs may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.

Drug/Laboratory Test Interactions

Combipresan (Chlorthalidone) and related drugs may decrease serum PBI levels without signs of thyroid disturbance.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No information available.

Pregnancy

Reproduction studies have been performed in the rat and the rabbit at doses up to 420 times the human dose and have revealed no evidence of harm to the fetus due to Combipresan. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nonteratogenic Effects

Thiazides cross the placental barrier and appear in cord blood. The use of Combipresan (Chlorthalidone) and related drugs in pregnant women requires that the anticipated benefits of the drug be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in the adult.

Nursing Mothers

Thiazides are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Combipresan (Chlorthalidone), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children has not been established.

ADVERSE REACTIONS:

To report SUSPECTED ADVERSE REACTIONS, please call RiconPharma LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The following adverse reactions have been observed, but there is not enough systematic collection of data to support an estimate of their frequency.

Gastrointestinal System Reactions: anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis.

Central Nervous System Reactions: dizziness, vertigo, paresthesias, headache, xanthopsia.

Hematologic Reactions: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia.

Dermatologic-Hypersensitivity Reactions: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis, cutaneous vasculitis), Lyell’s syndrome (toxic epidermal necrolysis).

Cardiovascular Reactions: orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates, or narcotics.

Other Adverse Reactions: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness, impotence.

Whenever adverse reactions are moderate or severe, Combipresan (Chlorthalidone) dosage should be reduced or therapy withdrawn.

OVERDOSAGE

Symptoms of acute overdosage include nausea, weakness, dizziness, and disturbances of electrolyte balance. The oral LD₅₀ of the drug in the mouse and the rat is more than 25,000 mg/kg body weight. The minimum lethal dose (MLD) in humans has not been established. There is no specific antidote, but gastric lavage is recommended, followed by supportive treatment. Where necessary, this may include intravenous dextrose-saline with potassium, administered with caution.

DOSAGE AND ADMINISTRATION:

Therapy should be initiated with the lowest possible dose. This dose should be titrated according to individual patient response to gain maximal therapeutic benefit while maintaining lowest dosage possible. A single dose given in the morning with food is recommended; divided daily doses are unnecessary.

Hypertension

Initiation: Therapy, in most patients, should be initiated with a single daily dose of 25 mg. If the response is insufficient after a suitable trial, the dosage may be increased to a single daily dose of 50 mg. If additional control is required, the dosage of Combipresan (Chlorthalidone) may be increased to 100 mg once daily or a second antihypertensive drug (step 2 therapy) may be added. Dosage above 100 mg daily usually does not increase effectiveness. Increases in serum uric acid and decreases in serum potassium are dose-related over the 25 to 100 mg/day range.

Maintenance: Maintenance doses may be lower than initial doses and should be adjusted according to individual patient response. Effectiveness is well sustained during continued use.

Edema

Initiation: Adults, initially 50 to 100 mg daily, or 100 mg on alternate days. Some patients may require 150 to 200 mg at these intervals or up to 200 mg daily. Dosages above this level, however, do not usually produce a greater response.

Maintenance: Maintenance doses may often be lower than initial doses and should be adjusted according to individual patient response. Effectiveness is well sustained during continued use.

HOW SUPPLIED:

Combipresan (Chlorthalidone) Tablets, USP are available containing 25 mg or 50 mg of Combipresan (Chlorthalidone), USP.

The 25 mg tablets are green colored, biconvex, round shaped tablets debossed with ‘010’ on one side, and plain on the other side. They are available as follows:

NDC 51125-010-06

Bottles of 100 tablets

NDC 51125-010-09

Bottles of 1000 tablets

The 50 mg tablets are green colored, capsule shaped tablets debossed with ‘011’ on one side, and a break-line on the other side. They are available as follows:

NDC 51125-011-06

Bottles of 100 tablets

NDC 51125-011-09

Bottles of 1000 tablets

Store at 20ºC to 25º C (68º to 77º F).

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

ANIMAL

Pharmacology:

Biochemical studies in animals have suggested reasons for the prolonged effect of Combipresan (Chlorthalidone). Absorption from the gastrointestinal tract is slow due to its low solubility. After passage to the liver, some of the drug enters the general circulation, while some is excreted in the bile, to be reabsorbed later. In the general circulation, it is distributed widely to the tissue, but is taken up in highest concentrations by the kidneys, where amounts have been found 72 hours after ingestion, long after it has disappeared from other tissues. The drug is excreted unchanged in the urine.

Manufactured for:

RiconPharma LLC.

Denville, NJ, 07834

Made in U.S.A

PC143 Revised: 03/17

Clonidine Hydrochloride:

• Combipresan information
• Combipresan indications
• Combipresan warnings
• Combipresan intake guidelines
• Combipresan dosage
• Combipresan overdose
• Combipresan missed dose
• Combipresan side effects
• Combipresan drug reactions
• Combipresan (Clonidine Hydrochloride) reviews

Combipresan information

Combipresan (Clonidine Hydrochloride) is a medicine that is meant to lower the patient's blood pressure. It achieves its purpose as it decreases the levels in which certain chemicals are found in the patient's blood. In this way, the veins and arteries are allowed to widen, enabling the heart to beat regularly.

Combipresan indications

Combipresan (Clonidine Hydrochloride) is normally used in the treatment of hypertension (also known as high blood pressure). But Combipresan (Clonidine Hydrochloride) can also be used for other purposes that have not been mentioned here.

Combipresan warnings

This drug ought to be taken in on a regular basis. You should refrain from stopping your treatment without your personal physician's consent because this may lead to some of the following medical conditions:

Dangerously high blood pressure

Anxiety

Nervousness

A treatment with Combipresan (Clonidine Hydrochloride) could induce drowsiness or dizziness therefore caution is needed if the patient has to operate complicated machinery or to perform dangerous activities. During the patient's treatment with Combipresan (Clonidine Hydrochloride) he or she should refrain from taking in alcohol, pain relievers, antihistamines, sleeping pills or any other medicines without his or her doctor's approval.

You might not be allowed to follow a treatment with Combipresan (Clonidine Hydrochloride) if you are suffering from any of the next disorders:

Heart disease (heart attack)

Stroke

Kidney disease

Liver disease

If you are suffering from any of the ailments that have been mentioned here you might be told by your doctor not to start a treatment with Combipresan (Clonidine Hydrochloride) or he (or she) might want to adjust your dosage of the drug or to monitor your body's reaction to the treatment.

Combipresan (Clonidine Hydrochloride) is a Category C FDA pregnancy drug, meaning that it has not been established whether a treatment with it could harm pregnant women, nor is it known whether it can lead to unwanted birth defects. During the pregnancy's third trimester a treatment with Combipresan (Clonidine Hydrochloride) should be avoided. If you are pregnant or are planning to be so soon, you should consult with your doctor before starting a treatment with this drug. If you are breastfeeding an infant you should not start taking this medicine without consulting it with your physician.

Lower dosages are usually needed for patients over 60.

Combipresan intake guidelines

Follow the instructions that your doctor has given you regarding your treatment with Combipresan (Clonidine Hydrochloride) Sanis Health. If you have any further questions, ask your doctor, a pharmacist or a nurse. You should accompany each and every dose of Combipresan (Clonidine Hydrochloride) that you take with a glass of water. It is recommended that you take the drug before bed time. Do not stop your treatment with Combipresan (Clonidine Hydrochloride) without your doctor's consent.

Combipresan dosage

Ask your doctor to calculate the dose of Combipresan (Clonidine Hydrochloride) that suits you best. The correct dosage varies from one person to another, as it depends on a couple of factors.

Combipresan overdose

Overdose of Combipresan (Clonidine Hydrochloride) usually leads to the next symptoms:

Drowsiness

Weakness

Lethargy

Slower heart rate

Lightheadedness

Vomiting

Nausea

Seizures

If you are experiencing any of the symptoms listed here, you are in need of medical attention (inform your doctor immediately).

Combipresan missed dose

Combipresan (Clonidine Hydrochloride) should be taken in or on a regular basis. If you are following a treatment with Combipresan (Clonidine Hydrochloride) Sanis Health, try not to miss any of your doses. If you happen to miss one take it as soon as possible and continue with your regular schedule. You should not take in a double dose of this drug unless you are instructed by your physician to do so.

Combipresan side effects

Taking Combipresan (Clonidine Hydrochloride) may result in some of these side effects:

Difficulty while breathing

Throat closing

Hives

Swelling of the tongue, face or lips

Slow hear rate (lower than 60 beats / minute)

Abnormal low or high blood pressure (headache, fainting, redness of the neck, face and chest, sometimes dizziness)

If you are experiencing these side effects stop your treatment and inform your physician.

Combipresan (Clonidine Hydrochloride) can also induce other side effects (more common and less serious) such as:

Abnormal fatigue, tiredness or dizziness

Diarrhea

Headache

Constipation, vomiting and nausea

Dry mouth

Insomnia

These mild side effects shouldn't stop you from continuing with your treatment. However, you should inform your doctor at once.

Other side effects may also occur when you take Combipresan (Clonidine Hydrochloride) Sanis Health. Inform your physician immediately if you experience anything unusual while taking this drug.

Combipresan drug reactions

Combipresan (Clonidine Hydrochloride) is known to cause drowsiness. Taking in alcohol, antidepressants, sedatives, antihistamines, pain relievers, drugs for anxiety or muscle relaxants could increase this side effect of Combipresan (Clonidine Hydrochloride) Sanis Health. Avoid taking them during your treatment with Combipresan (Clonidine Hydrochloride) Sanis Health.

Combipresan (Clonidine Hydrochloride) may interact with some of these drugs so it is best that you avoid taking them during your treatment with this drug:

Beta blockers

Prazosin

Levodopa

Tricyclic antidepressant

Verapamil

There are other drugs which may also interact with Combipresan (Clonidine Hydrochloride) Sanis Health. Inform your physician if you are taking any other drugs except Combipresan (Clonidine Hydrochloride) Sanis Health.