Chlorothiazide Injection

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how chlorothiazide injection affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Have your blood pressure checked often. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
• If you are taking chlorothiazide injection and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• This medicine is a strong fluid-lowering drug (diuretic). Sometimes too much water and major elements (potassium) in the blood may be lost. This can lead to serious health problems. Your doctor will follow you closely to change the dose to match your body's needs.
• You may need extra potassium. Talk with your doctor.
• If you are on a low-salt or salt-free diet, talk with your doctor.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Watch for gout attacks.
• If you have lupus, this medicine can make your lupus active or get worse. Tell your doctor right away if you get any new or worse signs.
• If you are taking lithium, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with chlorothiazide injection.
• This medicine may make you sunburn more easily. Use care if you will be in the sun. Tell your doctor if you sunburn easily while taking this drug.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using chlorothiazide injection while you are pregnant.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Feeling tired or weak.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Upset stomach or throwing up.
• Stomach cramps.
• Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store chlorothiazide injection at home, talk with your doctor, nurse, or pharmacist about how to store it.

Intravenous use in infants and children has been limited and is not generally recommended.

Use with caution in severe renal disease.  In patients with renal disease, thiazides may precipitate azotemia.  Cumulative effects of the drug may develop in patients with impaired renal function.

Thiazides 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.

Thiazides may add to or potentiate the action of other antihypertensive drugs.

Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.

Lithium generally should not be given with diuretics (see PRECAUTIONS, Drug Interactions).

Chlorothiazide sodium for injection should be reserved for patients unable to take oral medication or for emergency situations.

Therapy should be individualized according to patient response.  Use the smallest dosage necessary to achieve the required response.

Intravenous use in infants and children has been limited and is not generally recommended.

When medication can be taken orally, therapy with chlorothiazide tablets or oral suspension may be substituted for intravenous therapy, using the same dosage schedule as for the parenteral route.

Chlorothiazide sodium for injection may be given slowly by direct intravenous injection or by intravenous infusion.

Extravasation must be rigidly avoided.  Do not give subcutaneously or intramuscularly.

The usual adult dosage is 500 mg to 1 g once or twice a day.  Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week.  With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.

Directions for Reconstitution

Use aseptic technique.  Because chlorothiazide sodium for injection contains no preservative, a fresh solution should be prepared immediately prior to each administration, and the unused portion should be discarded.

Add 18 mL of Sterile Water for Injection to the vial to form an isotonic solution for intravenous injection.  Never add less than 18 mL.  When reconstituted with 18 mL of Sterile Water, the final concentration of intravenous chlorothiazide sodium is 28 mg/mL.  The reconstituted solution is clear and essentially free from visible particles.  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit.  The solution is compatible with dextrose or sodium chloride solutions for intravenous infusion.  Avoid simultaneous administration of solutions of chlorothiazide with whole blood or its derivatives.

Chlorothiazide Sodium for Injection, USP is a dry, sterile lyophilized powder, supplied as follows:

 The container closure is not made with natural rubber latex.

Storage

STORE LYOPHILIZED POWDER BETWEEN:  2° and 25°C (36° and 77°F).

For single dose only.  Use solution immediately after reconstitution (see DOSAGE AND ADMINISTRATION, Directions for Reconstitution).  Discard unused portion of the reconstituted solution.

PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.

Manufactured by:

Fresenius Kabi
Lake Zurich, IL 60047

www.fresenius-kabi.us

451314A

Revised: March  2017

 

PACKAGE LABEL - PRINCIPAL PANEL - Chlorothiazide 500 mg* per vial Label

Chlorothiazide Sodium

for Injection, USP
500 mg* per vial

For the preparation of intravenous solutions.

Rx only

Single Dose Vial

PACKAGE LABEL - PRINCIPAL PANEL - Chlorothiazide 500 mg* per vial Carton Panel
Chlorothiazide Sodium

for Injection, USP

500 mg* per vial

For the preparation of intravenous solutions.

Rx only

Single Dose Vial