Patient Medication Information: uses, side effects, how to take - Nu-Hydro
ABOUT THIS MEDICATION
What the medication is used for:
NU-HYDRO has been prescribed to you for edema (swelling) associated with heart failure, cirrhosis of the liver, corticosteroid and estrogen therapy and for edema originating from the kidneys; or hypertension; or toxemia (hypertension) due to pregnancy.
What it does:
NU-HYDRO elevates the rate of urine secretion and lowers blood pressure.
Hydrochlorothiazide affects the kidneys ability to reabsorb electrolytes. It increases excretion of sodium and chloride in approximately equivalent amounts and reduces the rate of formation of solute-free water.
When it should not be used:
You should not use NU-HYDRO if you:
Are allergic to Hydrochlorothiazide or to other
sulfonamide-derived drugs.
Are allergic to any of the other ingredients in the
product (please see “What the nonmedicinal ingredients are”).
- Have no production of urine.
Experience an increase of urea or creatinine and
a decrease in urine production during treatment of severe progressive kidney disease.
Stop taking the drug and contact your doctor immediately if you experience an allergic reaction or any severe or unusual side effects.
What the medicinal ingredient is:
Hydrochlorothiazide
What the important nonmedicinal ingredients are:
colloidal silicon dioxide, lactose monohydrate (spray dried), magnesium stearate, microcrystalline cellulose, starch (corn) and sunset yellow aluminum lake 40%
What dosage forms it comes in:
Tablets: 12.5 mg
WARNINGS AND PRECAUTIONS
Before starting NU-HYDRO talk to your doctor or pharmacist:
- If you are taking enteric-coated potassium salts
- If you have impaired liver function or progressive liver disease
- If you have impaired kidney function
- If you are taking anti-hypertensive medication or other adrenergic blocking drugs
- If you have a history of sensitivity reactions or a history of allergic reactions to this or other medications
- If you have lupus
Remember to keep this and other medications away from children.
Tell your physician or pharmacist all medication you are taking, including any non-prescription or herbal medicines
Other precautions:
Do not take NU-HYDRO if you are:
- Pregnant or breast-feeding
- Are allergic to any of it’s ingredients
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with NU-HYDRO include:
- Lithium. Concomitant therapy with lithium is not recommended with NU-HYDRO because of the reduction of kidney clearance of lithium and therefore an added risk of lithium toxicity.
Orthostatic hypotension (low blood pressure while you are standing) may occur and may be enhanced by alcohol, barbiturates, or narcotics.
You should always tell your physician about all drugs you are taking, including those obtained without a prescription.
PROPER USE OF THIS MEDICATION
Take this medicine exactly as prescribed by your physician.
Adult Patients
Diuresis
The recommended adult dosage is 50 to 100 mg once or twice a day. Many patients respond to intermittent therapy, i.e. administration on alternate days or on three to five days each week.
Toxemia of pregnancy
The recommended dosage is 100 mg daily, or in severe cases and for brief periods, 200 mg daily (in divided doses). Frequency of administration may range from once every four days to daily.
Premenstrual tension with swelling
The recommended dosage is 25 to 50 mg once or twice a day from the first appearance of symptoms until the onset of menses.
Control of Hypertension
The usual recommended starting dosage is 50 or 100 mg a day as a single or divided dose. Dosage is increased or decreased according to the blood pressure response of the patient. Some patients may require doses of 200 mg a day in divided doses.
Infants and Children
The usual recommended pediatric dosage is based on 1.0 mg of NU-HYDRO per pound of body weight per day in two doses. Infants under 6 months of age may require up to 1.5 mg per pound per day in two doses.
On this basis, infants up to 2 years of age may be given 12 .5 to 37.5 mg daily in two doses.
Overdose:
If you take too many doses, contact your physician, hospital emergency department or regional poison control centre.
Missed Dose:
If you miss a dose, and it is close to the next scheduled dose, take your medicine at the next scheduled time. Do NOT double dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Gastrointestinal: Decreased appetite, gastric irritation, nausea, vomiting, cramps, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), inflammation of the pancreas, inflammation or enlargement of salivary glands.
Central nervous system: Dizziness, a feeling that you or your surroundings are moving, sensation of tingling or numbness, headache, impaired sense of sight.
Hematologic: Blood conditions such as leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia. Cardiovascular: Postural hypotension (low blood pressure aggravated by position) may be aggravated by alcohol, barbiturates, or narcotics.
Hypersensitivity: Spontaneous bleeding under the skin, sensitivity to light, rash, red patches on the skin, fever, respiratory distress including pneumonitis, anaphylactic (allergic) reactions.
Other: Hyperglycemia, muscle spasm, weakness, restlessness, transient blurred vision.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||||
| Only if severe | In all cases | |||||
Allergic reactions (swelling, skin rash, itching) | Ã | |||||
| Chest pain | Ã | |||||
Stomach ulcer (burning pain in the gut, vomiting…) | Ã | |||||
Blood Problems (loss of energy, low blood platelet count…) | Ã | |||||
| Imbalance of minerals in the blood | Ã | |||||
This is not a complete list of side effects. For any unexpected effects while taking NU-HYDRO contact your doctor or pharmacist.
HOW TO STORE IT
Store at controlled room temperature 15°C to
30°C (59° to 86°F).
- Keep out of the reach and sight of children.
- Do not use after the expiry date indicated on the package.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated wit the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and: -Fax toll-free to 1-866-678-6789, or -Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701C
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the Med Effect ™ Canada Web site at www.healtlcanada.gc.ca/medeffect.
NOTE: Should you require information related to the
management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Nu-Pharm, Inc. at:
1-800-267-1438
Date of Revision: October 9, 2009