Clorpropamida is an anti-psychotic medication in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain.
Clorpropamida is used to treat psychotic disorders such as schizophrenia or manic-depression, and severe behavioral problems in children ages 1 through 12.
Clorpropamida is also used to treat nausea and vomiting, anxiety before surgery, chronic hiccups, acute intermittent porphyria, and symptoms of tetanus.
Clorpropamida may also be used for purposes not listed in this medication guide.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Infectious-inflammatory diseases caused by microorganisms susceptible to ciprofloxacin, including respiratory diseases, diseases of abdominal and pelvic organs, bones, joints, skin, septicemia; severe infections of ENT organs. Treatment of postoperative infections. Prevention and treatment of infections in patients with reduced immunity.
For Clorpropamida Basic Pharmaceutical Corporation local use: acute and subacute conjunctivitis, blepharoconjunctivitis, blepharitis, bacterial corneal ulcers, keratitis, keratoconjunctivitis, chronic dacryocystitis, meybomity. Infectious lesions in the eyes from injury or contact with foreign bodies. Preoperative prophylaxis in ophthalmic surgery.
How should I use Clorpropamida?
Use Clorpropamida as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Clorpropamida is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Clorpropamida at home, a health care provider will teach you how to use it. Be sure you understand how to use Clorpropamida. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Clorpropamida if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Clorpropamida may irritate skin. Avoid contact with skin or clothing. Wear rubber gloves while using Clorpropamida.
Do not suddenly stop taking Clorpropamida.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Clorpropamida and you are using it regularly, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Clorpropamida.
Uses of Clorpropamida in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Behavioral problems: Treatment of severe behavioral problems in children 1 to 12 years of age marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations).
Bipolar disorder: Treatment of manic episodes associated with bipolar disorder.
Hiccups: Treatment of intractable hiccups.
Hyperactivity: Short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressiveness, mood lability, and poor frustration tolerance.
Nausea/Vomiting: Management of nausea and vomiting.
Porphyria, acute intermittent: Treatment of acute intermittent porphyria.
Schizophrenia/Psychotic disorders: Treatment of schizophrenia and psychotic disorders.
Surgery: Management of restlessness and apprehension prior to surgery.
Tetanus: Adjunctive therapy in the treatment of tetanus.
Off Label Uses
Nausea and vomiting of pregnancy
Based on the American College of Obstetricians and Gynecologists (ACOG) Nausea and Vomiting in Pregnancy guidelines, the use of Clorpropamida may be considered for adjunctive treatment of nausea and vomiting in pregnant women. Use is reserved for women with dehydration when symptoms persist following preferred pharmacologic therapies.
A carbamate with hypnotic, sedative, and some muscle relaxant properties, although in therapeutic doses reduction of anxiety rather than a direct effect may be responsible for muscle relaxation. Clorpropamida has been reported to have anticonvulsant actions against petit mal seizures, but not against grand mal seizures (which may be exacerbated). It is used in the treatment of anxiety disorders, and also for the short-term management of insomnia but has largely been superseded by the benzodiazepines. (From Martindale, The Extra Pharmacopoeia, 30th ed, p603) Clorpropamida is a controlled substance in the U.S.
Adjust dosage to individual and the severity of his condition, recognizing that the milligram for milligram potency relationship among all dosage forms has not been precisely established clinically. It is important to increase dosage until symptoms are controlled. Dosage should be increased more gradually in debilitated or emaciated patients. In continued therapy, gradually reduce dosage to the lowest effective maintenance level, after symptoms have been controlled for a reasonable period.
In general, dosage recommendations for other oral forms of the drug may be applied to Spansule® brand sustained release capsules on the basis of total daily dosage in milligrams.
The 100 mg and 200 mg tablets are for use in severe neuropsychiatric conditions.
Increase parenteral dosage only if hypotension has not occurred. Before using I.M., see IMPORTANT NOTES ON INJECTION.
Elderly Patients — In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.
Psychotic Disorders — Increase dosage gradually until symptoms are controlled. Maximum improvement may not be seen for weeks or even months. Continue optimum dosage for 2 weeks; then gradually reduce dosage to the lowest effective maintenance level. Daily dosage of 200 mg is not unusual. Some patients require higher dosages (e.g., 800 mg daily is not uncommon in discharged mental patients).
HOSPITALIZED PATIENTS: ACUTE SCHIZOPHRENIC OR MANIC STATES — I.M.: 25 mg (1 mL). If necessary, give additional 25 to 50 mg injection in 1 hour. Increase subsequent I.M. doses gradually over several days— up to 400 mg q4 to 6h in exceptionally severe cases— until patient is controlled. Usually patient becomes quiet and cooperative within 24 to 48 hours and oral doses may be substituted and increased until the patient is calm. 500 mg a day is generally sufficient. While gradual increases to 2,000 mg a day or more may be necessary, there is usually little therapeutic gain to be achieved by exceeding 1,000 mg a day for extended periods. In general, dosage levels should be lower in the elderly, the emaciated and the debilitated. LESS ACUTELY DISTURBED—
Oral: 25 mg t.i.d. Increase gradually until effective dose is reached— usually 400 mg daily. OUTPATIENTS—
Oral: 10 mg t.i.d. or q.i.d., or 25 mg b.i.d. or t.i.d. MORE SEVERE CASES—
Oral: 25 mg t.i.d. After 1 or 2 days, daily dosage may be increased by 20 to 50 mg at semiweekly intervals until patient becomes calm and cooperative. PROMPT CONTROL OF SEVERE SYMPTOMS— I.M.: 25 mg (1 mL). If necessary, repeat in 1 hour. Subsequent doses should be oral, 25 to 50 mg t.i.d.
Nausea and Vomiting —
Oral: 10 to 25 mg q4 to 6h, p.r.n., increased, if necessary. I.M.: 25 mg (1 mL). If no hypotension occurs, give 25 to 50 mg q3 to 4h, p.r.n., until vomiting stops. Then switch to oral dosage. Rectal: One 100 mg suppository q6 to 8h, p.r.n. In some patients, half this dose will do.
DURING SURGERY— I.M.: 12.5 mg (0.5 mL). Repeat in 1 / 2 hour if necessary and if no hypotension occurs. I.V.: 2 mg per fractional injection, at 2-minute intervals. Do not exceed 25 mg. Dilute to 1 mg/mL, i.e., 1 mL (25 mg) mixed with 24 mL of saline.
Presurgical Apprehension —
Oral: 25 to 50 mg, 2 to 3 hours before the operation. I.M.: 12.5 to 25 mg (0.5 to 1 mL), 1 to 2 hours before operation.
Intractable Hiccups —
25 to 50 mg t.i.d. or q.i.d. If symptoms persist for 2 to 3 days, give 25 to 50 mg (1 to 2 mL) I.M. Should symptoms persist, use slow I.V. infusion with patient flat in bed: 25 to 50 mg (1 to 2 mL) in 500 to 1,000 mL of saline. Follow blood pressure closely.
Acute Intermittent Porphyria —
Oral: 25 to 50 mg t.i.d. or q.i.d. Can usually be discontinued after several weeks, but maintenance therapy may be necessary for some patients. I.M.: 25 mg (1 mL) t.i.d. or q.i.d. until patient can take oral therapy.
Tetanus — I.M.: 25 to 50 mg (1 to 2 mL) given 3 or 4 times daily, usually in conjunction with barbiturates. Total doses and frequency of administration must be determined by the patient's response, starting with low doses and increasing gradually. I.V.: 25 to 50 mg (1 to 2 mL). Dilute to at least 1 mg per mL and administer at a rate of 1 mg per minute.
DOSAGE AND ADMINISTRATION— PEDIATRIC PATIENTS (6 months to 12 years of age)
Clorpropamida (Clorpropamida) should generally not be used in pediatric patients under 6 months of age except where potentially lifesaving. It should not be used in conditions for which specific pediatric dosages have not been established.
Severe Behavioral Problems — OUTPATIENTS— Select route of administration according to severity of patient's condition and increase dosage gradually as required.
Oral: 1 / 4 mg/lb body weight q4 to 6h, p.r.n. (e.g., for 40 lb child— 10 mg q4 to 6h). Rectal: 1 / 2 mg/lb body weight q6 to 8h, p.r.n. (e.g., for 20 to 30 lb child— half a 25 mg suppository q6 to 8h). I.M.: 1 / 4 mg/lb body weight q6 to 8h, p.r.n.
HOSPITALIZED PATIENTS— As with outpatients, start with low doses and increase dosage gradually. In severe behavior disorders, higher dosages (50 to 100 mg daily, and in older children, 200 mg daily or more) may be necessary. There is little evidence that behavior improvement in severely disturbed mentally retarded patients is further enhanced by doses beyond 500 mg per day. Maximum I.M.
Dosage: Children up to 5 years (or 50 lbs), not over 40 mg/day; 5 to 12 years (or 50 to 100 lbs), not over 75 mg/day except in unmanageable cases.
Nausea and Vomiting — Dosage and frequency of administration should be adjusted according to the severity of the symptoms and response of the patient. The duration of activity following intramuscular administration may last up to 12 hours. Subsequent doses may be given by the same route if necessary.
Oral: 1 / 4 mg/lb body weight (e.g., 40 lb child— 10 mg q4 to 6h). Rectal: 1 / 2 mg/lb body weight q6 to 8h, p.r.n. (e.g., 20 to 30 lb child— half of a 25 mg suppository q6 to 8h). I.M.: 1 / 4 mg/lb body weight q6 to 8h, p.r.n. Maximum I.M.
Dosage: Pediatric patients 6 months to 5 yrs. (or 50 lbs), not over 40 mg/day; 5 to 12 yrs. (or 50 to 100 lbs), not over 75 mg/day except in severe cases. DURING SURGERY— I.M.: 1 / 8 mg/lb body weight. Repeat in 1 / 2 hour if necessary and if no hypotension occurs. I.V.: 1 mg per fractional injection at 2-minute intervals and not exceeding recommended I.M. dosage. Always dilute to 1 mg/ mL, i.e., 1 mL (25 mg) mixed with 24 mL of saline.
Presurgical Apprehension — 1 / 4 mg/lb body weight, either orally 2 to 3 hours before operation, or I.M. 1 to 2 hours before.
Tetanus — I.M. or I.V.: 1 / 4 mg/lb body weight q6 to 8h. When given I.V., dilute to at least 1 mg/mL and administer at rate of 1 mg per 2 minutes. In patients up to 50 lbs, do not exceed 40 mg daily; 50 to 100 lbs, do not exceed 75 mg, except in severe cases.
Important Notes On Injection
Inject slowly, deep into upper outer quadrant of buttock.
Because of possible hypotensive effects, reserve parenteral administration for bedfast patients or for acute ambulatory cases, and keep patient lying down for at least 1 / 2 hour after injection. If irritation is a problem, dilute Injection with saline or 2% procaine; mixing with other agents in the syringe is not recommended. Subcutaneous injection is not advised. Avoid injecting undiluted Clorpropamida (Clorpropamida) into vein. I.V. route is only for severe hiccups, surgery and tetanus.
Because of the possibility of contact dermatitis, avoid getting solution on hands or clothing. This solution should be protected from light. This is a clear, colorless to pale yellow solution; a slight yellowish discoloration will not alter potency. If markedly discolored, solution should be discarded. For information on sulfite sensitivity, see the WARNINGS section of this labeling.
Note on Concentrate: When the Concentrate is to be used, add the desired dosage of Concentrate to 60 mL (2 fl oz) or more of diluent just prior to administration. This will insure palatability and stability. Vehicles suggested for dilution are: tomato or fruit juice, milk, simple syrup, orange syrup, carbonated beverages, coffee, tea or water. Semisolid foods (soups, puddings, etc.) may also be used. The Concentrate is light sensitive; it should be protected from light and dispensed in amber glass bottles. Refrigeration is not required.
Tablets: 10 mg, in bottles of 100; 25 mg or 50 mg, in bottles of 100 and 1000. For use in severe neuropsychiatric conditions, 100 mg and 200 mg, in bottles of 100 and 1000.
NDC 0007-5073-20 10 mg 100's
NDC 0007-5074-20 25 mg 100's
NDC 0007-5074-30 25 mg 1000's
NDC 0007-5076-20 50 mg 100's
NDC 0007-5076-30 50 mg 1000's
NDC 0007-5077-20 100 mg 100's
NDC 0007-5077-30 100 mg 1000's
NDC 0007-5079-20 200 mg 100's
NDC 0007-5079-30 200 mg 1000's
Spansule® brand of sustained release capsules: 30 mg, 75 mg or 150 mg, in bottles of 50.
NDC 0007-5063-15 30 mg 50's
NDC 0007-5064-15 75 mg 50's
NDC 0007-5066-15 150 mg 50's
Ampuls: 1 mL and 2 mL (25 mg/mL), in boxes of 10.
NDC 0007-5060-11 25 mg/mL in 1 mL Ampuls (box of 10)
NDC 0007-5061-11 25 mg/mL in 2 mL Ampuls (box of 10)
Multi-Dose Vials: 10 mL (25 mg/mL), in boxes of 1.
NDC 0007-5062-01 25 mg/mL in 10 mL Multi-Dose Vials (box of 1)
Syrup: 10 mg/5 mL, in 4 fl oz bottles.
NDC 0007-5072-44 10 mg/5 mL 4 fl oz
Suppositories: 25 mg or 100 mg, in boxes of 12.
NDC 0007-5070-03 25 mg (box of 12)
NDC 0007-5071-03 100 mg (box of 12)
All dosage forms except Syrup should be stored between 15° and 30°C (59° and 86°F). Syrup should be stored below 25°C (77°F).
WARNING: Clorpropamida® (Clorpropamida) Spansule capsules are manufactured with carbon tetrachloride and methyl chloroform, substances which harm public health and environment by destroying ozone in the upper atmosphere.
FDA revision date: 4/22/1998. Manufacturer information: n/a
Alcohol, barbiturates and other sedatives may intensify the CNS depressant effects of Clorpropamida and respiratory depression may occur.
The hypotensive effect of most antihypertensive agents, especially alpha-adrenoceptor blocking agents, may be exaggerated by Clorpropamida.
Clorpropamida has mild anticholinergic activity which may be enhanced by other anticholinergic drugs.
Anticholinergic drugs may decrease the antipsychotic effect of Clorpropamida. Clorpropamida may oppose the action of some drugs, including amphetamine, levodopa, adrenaline, clonidine and guanethidine.
Some drugs interfere with the absorption of neuroleptic agents, e.g. antacids, lithium, anti-Parkinsonian agents. Although increases or decreases have been observed in the plasma concentrations of a number of drugs, including propranolol and phenobarbitone, these were not of clinical significance.
At high dosage, Clorpropamida reduces the response to hypoglycaemic agents, which may require an increase in dosage of the latter.
Clinically significant adverse drug interactions with alcohol, guanethidine and hypoglycaemic agents are documented. Adrenaline must not be used in cases of overdosage with Clorpropamida. Other interactions are of theoretical interest and are not of a serious nature. Concomitant administration of desferrioxamine and prochlorperazine has been reported to cause a transient metabolic encephalopathy with loss of consciousness for 48 to 72 hours. The possibility of a similar occurrence with Clorpropamida exists, because it shares many of the pharmacological activities of prochlorperazine.
Minor Adverse Reaction: Nasal stuffiness, dry mouth, insomnia, agitation.
Liver Function: Jaundice, usually transient, occurs in a very small percentage of patients taking Clorpropamida. A premonitory sign may be sudden onset of fever after 1-3 weeks of treatment followed by the development of jaundice. Clorpropamida jaundice has the biochemical and other characteristics of obstructive jaundice and is associated with obstructions of the canaliculi by bile thrombi; the frequent resence of an accompanying eosinophilia indicates the allergic nature of this phenomenon. Treatment should be withheld on the development of jaundice.
Cardio-Respiratory: Hypotension, usually postural, commonly occurs. Elderly or volume-depleted subjects are particularly susceptible; it is more likely to occur after IM administration.
Cardiac arrhythmias, including atrial arrhythmia, AV block, ventricular tachycardia and fibrillation have been reported during neurologic therapy, possibly related to dosage. Preexisting cardiac dosage, old age, hypokalemia and concurrent tricyclic antidepressants may predispose. ECG changes, usually benign, include widened QT interval, ST depression, U-waves and T-waves changes.
Respiratory depression is possible in susceptible patients.
Blood: A mild leucopenia occurs in up to 30% of patients on prolonged high dosage. Agranulocytosis may occur rarely; it is not dose-related. The occurrence of unexplained infections or fever requires immediate hematological investigation.
Extrapyramidal: Acute dystonias or dykinesias, usually transitory are more common in children and young adults and usually occur within the first 4 days of treatment or after dosage increases.
Akathisia characteristically occurs after large initial doses.
Parkinsonism is more common in adults and the elderly. It usually develops after weeks or months of treatment. One or more of the following may be seen: Tremor, rigidity, akinesia or other features of parkinsonism. Commonly, just tremor.
Tardive Dyskinesia: If this occurs, is it usually but not necessarily, after prolonged or high dosage. It can even occur after treatment has been stopped. Dosage should be kept low whenever possible.
Skin and Eyes: Contact skin sensitization is a serious but rare complication in those frequently handling preparations of Clorpropamida. The greatest care must be taken to avoid contact of Clorpropamida with the skin. Skin rashes of various kinds may also be seen in patients treated with Clorpropamida. Patients on high dosage should be warned that they may develop photosensitivity in sunny weather and should avoid exposure to direct sunlight.
Stop using this medication and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects.
Clorpropamida is not for use in psychotic conditions related to dementia. Clorpropamida may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.
Do not use Clorpropamida if you have brain damage, bone marrow depression, or are also using large amounts of alcohol or medicines that make you sleepy. Do not use if you are allergic to Clorpropamida or other phenothiazines.
Before you take Clorpropamida, tell your doctor if you have liver or kidney disease, heart disease or high blood pressure, glaucoma, severe breathing problems, past or present breast cancer, low levels of calcium in your blood, adrenal gland tumor, enlarged prostate or urination problems, a history of seizures, Parkinson's disease, or if you have ever had a serious side effect while using Clorpropamida or similar medicines.
Before taking Clorpropamida, tell your doctor about all other medications you use.
DailyMed. "CHLORPROPAMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
DailyMed. "CHLORPROMAZINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Clorpropamida are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Clorpropamida. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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