Clorpres

• Bertek Pharmaceuticals Inc.

• Mylan Bertek Pharmaceuticals Inc.

• Mylan Pharmaceuticals, Inc.

Clorpres is part of the drug classes:

• Low Ceiling Sulfonamide Diuretics

• Imidazoline receptor agonists

• Other antimigraine preparations

• Sympathomimetics in glaucoma therapy

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, weakness, drowsiness, limp feeling, pinpoint pupils, slow heart rate, shallow breathing, fainting, or seizure (convulsions).

Clonidine and chlorthalidone combinations are used in the treatment of high blood pressure (hypertension).

High blood pressure adds to the work load of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys resulting in a stroke, heart failure, or kidney failure. Hypertension may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Clonidine works by controlling nerve impulses along certain body nerve pathways. As a result, it relaxes blood vessels so that blood passes through them more easily. The chlorthalidone in this combination is a diuretic (water pill) that helps reduce the amount of water in the body by increasing the flow of urine.

Clonidine and chlorthalidone combination is available only with your doctor's prescription.

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly.

Check with your doctor before you stop taking this medicine. Your doctor may want you to reduce gradually the amount you are taking before stopping the medicine completely.

Make sure that you have enough medicine on hand to last through weekends, holidays, or vacations. You should not miss taking any doses. You may want to ask your doctor for another written prescription to carry in your wallet or purse. You can then have it filled if you run out of medicine when you are away from home.

Before having any kind of surgery (including dental surgery) or emergency treatment, make sure the medical doctor or dentist in charge knows that you are taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people to become drowsy or less alert than they are normally. This is more likely to happen when you begin to take it or when you increase the amount of medicine you are taking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help, but if the problem continues or gets worse, check with your doctor.

The dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. Drinking alcoholic beverages may also make the drowsiness worse. While you are taking this medicine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

This medicine may cause a loss of potassium from your body.

• To help prevent this, your doctor may want you to:
  • eat or drink foods that have a high potassium content (for example, orange or other citrus fruit juices), or
  • take a potassium supplement, or
  • take another medicine to help prevent the loss of the potassium in the first place.
• It is very important to follow these directions. Also, it is important not to change your diet on your own. This is more important if you are already on a special diet (as for diabetes), or if you are taking a potassium supplement or a medicine to reduce potassium loss. Extra potassium may not be necessary and, in some cases, too much potassium could be harmful.

Check with your doctor if you become sick and have severe or continuing vomiting or diarrhea. These problems may cause you to lose additional water and potassium.

For patients with diabetes:

• The chlorthalidone contained in this medicine may raise blood sugar levels. While you are using this medicine, be sure to test your blood sugar (glucose) level, or test for sugar in your urine.

This medicine may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block for lips that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Very bad dizziness or passing out.
• Change in eyesight.
• Yellow skin or eyes.
• A burning, numbness, or tingling feeling that is not normal.
• Fever or chills.
• Very bad sore throat.
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• Change in sex ability.
• Restlessness.

Clorpres® is a combination of clonidine hydrochloride (a centrally acting antihypertensive agent) and chlorthalidone (a diuretic). Clorpres® is available as tablets for oral administration in three dosage strengths: 0.1 mg/15 mg, 0.2 mg/15 mg and 0.3 mg/15 mg of clonidine hydrochloride/chlorthalidone, respectively.

The inactive ingredients are ammonium chloride, colloidal silicon dioxide, croscarmellose sodium (Type A), magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, D&C yellow #10.

Clonidine Hydrochloride

Clonidine hydrochloride, USP is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-[(2,6-dichlorophenyl)imino]imidazoline monohydrochloride. The following are the structural formula, molecular formula and molecular weight:

C9H9Cl2N3 .HCl    M. W. 266.56

Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol.

Chlorthalidone

Chlorthalidone, USP is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double ring system is incorporated in its structure. It is 2-chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl) benzenesulfonamide with the following structural formula, molecular formula and molecular weight:

C14H11Cl N2O4S      M. W. 338.76

Chlorthalidone is practically insoluble in water, in ether and in chloroform; soluble in methanol; slightly soluble in alcohol.

Chlorthalidone should be used with caution in severe renal disease. In patients with renal disease, chlorthalidone or related drugs may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function. Chlorthalidone should be used with caution in patients with impaired hepatic function or progressive liver disease, because 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 chlorthalidone. However, systemic lupus erythematosus has not been reported following chlorthalidone administration.

Clorpres® TABLETS (Clonidine Hydrochloride and Chlorthalidone Tablets, USP) are available containing:

0.1 mg clonidine hydrochloride, USP and 15 mg chlorthalidone, USP

or

0.2 mg clonidine hydrochloride, USP and 15 mg chlorthalidone, USP

or

0.3 mg clonidine hydrochloride, USP and 15 mg chlorthalidone, USP

The 0.1 mg/15 mg product is a yellow, round, scored tablet debossed with M above the score and 1 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-0001-01
bottles of 100 tablets

The 0.2 mg/15 mg product is a yellow, round, scored tablet debossed with M above the score and 27 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-0027-01
bottles of 100 tablets

The 0.3 mg/15 mg product is a yellow, round, scored tablet debossed with M above the score and 72 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-0072-01
bottles of 100 tablets

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

Keep this and all medication out of the reach of children.

Store at 20º to 25ºC (68º to 77ºF). [See USP for Controlled Room Temperature.]

Avoid excessive humidity.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

REVISED APRIL 2009
BKCLCH:R5

PRINCIPAL DISPLAY PANEL - 0.1 mg/15 mg

NDC 0378-0001-01

Clorpres®
(clonidine hydrochloride
and chlorthalidone
tablets, USP)

0.1 mg/
15 mg

Rx only      100 Tablets

Each tablet contains:
Clonidine Hydrochloride, USP    0.1 mg
Chlorthalidone, USP      15 mg

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

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Avoid excessive humidity.

Usual Adult Dosage: See
accompanying prescribing
information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RBK0001A2

PRINCIPAL DISPLAY PANEL - 0.2 mg/15 mg

NDC 0378-0027-01

Clorpres®
(clonidine hydrochloride
and chlorthalidone
tablets, USP)

0.2 mg/
15 mg

Rx only      100 Tablets

Each tablet contains:
Clonidine Hydrochloride, USP    0.2 mg
Chlorthalidone, USP      15 mg

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

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Avoid excessive humidity.

Usual Adult Dosage: See
accompanying prescribing
information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RBK0027A2

PRINCIPAL DISPLAY PANEL - 0.3 mg/15 mg

NDC 0378-0072-01

Clorpres®
(clonidine hydrochloride
and chlorthalidone
tablets, USP)

0.3 mg/
15 mg

Rx only      100 Tablets

Each tablet contains:
Clonidine Hydrochloride, USP    0.3 mg
Chlorthalidone, USP      15 mg

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

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Avoid excessive humidity.

Usual Adult Dosage: See
accompanying prescribing
information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RBK0072A2