Largactil 4% 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.
Largactil 4% is used to treat psychotic disorders such as schizophrenia or manic-depression, and severe behavioral problems in children ages 1 through 12.
Largactil 4% is also used to treat nausea and vomiting, anxiety before surgery, chronic hiccups, acute intermittent porphyria, and symptoms of tetanus.
Largactil 4% may also be used for purposes not listed in this medication guide.
Largactil 4% indications
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.
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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 Largactil 4% 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 Largactil 4%?
Use Largactil 4% as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Largactil 4% is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Largactil 4% at home, a health care provider will teach you how to use it. Be sure you understand how to use Largactil 4%. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Largactil 4% if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Largactil 4% may irritate skin. Avoid contact with skin or clothing. Wear rubber gloves while using Largactil 4%.
Do not suddenly stop taking Largactil 4%.
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 Largactil 4% 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 Largactil 4%.
Uses of Largactil 4% 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.
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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 Largactil 4% 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.
Largactil 4% description
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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. Largactil 4% 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) Largactil 4% is a controlled substance in the U.S.
Largactil 4% dosage
Largactil 4% Dosage
Applies to the following strength(s): 30 mg/mL; 100 mg/mL; 25 mg/mL; 30 mg; 75 mg; 150 mg; 25 mg; 100 mg; 10 mg/5 mL; 10 mg; 50 mg; 200 mg
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Adult Dose for:
Psychosis
Mania
Nausea/Vomiting
Light Sedation
Hiccups
Porphyria
Tetanus
Usual Pediatric Dose for:
Opiate Withdrawal
Schizophrenia
Nausea/Vomiting
Additional dosage information:
Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments
Usual Adult Dose for Psychosis
IM: Initial Dose 25 to 50 mg. The dose may be repeated in one hour. Subsequent doses may be increased and given every 2 to 4 hours as needed.
Oral: Initial Dose: 10 to 25 mg orally 3 times a day. Total daily doses should be increased in 20 to 50 mg increments every 3 or 4 days until symptoms are controlled.
Usual Maintenance Dose: 200 mg/day orally
Some patients require higher dosages (e.g., 800 mg daily is not uncommon in discharged mental patients). 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.
Usual Adult Dose for Mania
Oral: 10 mg orally 3 to 4 times a day or 25 mg orally 2 to 3 times a day.
More severe cases: 25 mg orally 3 times a day.
After 1 to 2 days, dose may be increased by 20 to 50 mg/day at semiweekly intervals.
Prompt control of severe symptoms: 25 mg IM one time.
If necessary, repeat in 1 hour. Subsequent doses should be oral, 25 to 50 mg three times a day.
IM: 25 mg injection one time. If necessary, may give additional 25 to 50 mg injection in 1 hour.
Increase subsequent doses gradually over several days up to 400 mg every 4 to 6 hours in exceptionally severe cases.
Usually patient becomes quiet and cooperative within 24 to 48 hours and oral doses may be substituted.
Oral: 500 mg/day is generally sufficient. Gradual increases to 2000 mg/day or more may be necessary.
There is usually little therapeutic gain to be achieved by exceeding 1000 mg/day for extended periods.
Less acutely disturbed
Oral: 25 mg three times a day.
May increase gradually until effective dose is reached, usually 400 mg/day.
Usual Adult Dose for Nausea/Vomiting
Oral: 10 to 25 mg every 4 to 6 hours as needed. May increase, if necessary.
IM: 25 mg one time. If no hypotension occurs, give 25 to 50 mg every 3 to 4 hours as needed, then switch to oral dosage.
Rectal: One 100 mg suppository every 6 to 8 hours as needed. In some patients, half this dose will do.
Nausea/Vomiting During Surgery:
IM: 12.5 mg one time. May repeat in 30 minutes if necessary and if no hypotension occurs.
IV: 2 mg at 2 minute intervals. Do not exceed 25 mg. Dilute to 1 mg/mL.
Usual Adult Dose for Light Sedation
For light sedation prior to a medical or surgical procedure:
Oral: 25 to 50 mg, 2 to 3 hours before the operation.
IM: 12.5 to 25 mg, 1 to 2 hours before operation.
Usual Adult Dose for Hiccups
Oral: 25 to 50 mg 3 to 4 times a day.
IM: If symptoms persist for 2 to 3 days, give 25 to 50 mg IM.
IV infusion: Should symptoms persist, use slow IV infusion: 25 to 50 mg in 500 to 1000 mL of saline.
Usual Adult Dose for Porphyria
Oral: 25 to 50 mg 3 to 4 times a day.
Can usually be discontinued after several weeks, but maintenance therapy may be necessary for some patients.
IM: 25 mg injection 3 to 4 times a day until patient can take oral therapy.
Usual Adult Dose for Tetanus
IM: 25 to 50 mg given 3 to 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.
IV: 25 to 50 mg diluted to at least 1 mg/mL and administered at a rate of 1 mg/min.
Usual Pediatric Dose for Opiate Withdrawal
less than 1 month:
Neonatal abstinence syndrome (withdrawal from maternal opioid use; controls CNS and gastrointestinal symptoms):
Intramuscular: Initial: 0.55 mg/kg/dose given every 6 hours; change to oral after approximately 4 days, decrease dose gradually over 2 to 3 weeks. Note: Largactil 4% is rarely used for neonatal abstinence syndrome due to adverse effects such as hypothermia, cerebellar dysfunction, decreased seizure threshold, and eosinophilia; other agents are preferred.
Usual Pediatric Dose for Schizophrenia
6 months and older:
Oral: 0.5 to 1 mg/kg/dose orally every 4 to 6 hours; older children may require 200 mg/day or higher
intramuscular or intravenous: 0.5 to 1 mg/kg/dose every 6 to 8 hours
Maximum recommended doses:
less than 5 years (less than 22.7 kg): 40 mg/day
5 years and older: (22.7 to 45.5 kg): 75 mg/day
Usual Pediatric Dose for Nausea/Vomiting
Nausea and vomiting:
Oral: 0.5 to 1 mg/kg/dose every 4 to 6 hours as needed
intramuscular or intravenous: 0.5 to 1 mg/kg/dose every 6 to 8 hours;
Maximum recommended doses:
less than 5 years (less than 22.7 kg): 40 mg/day
5 and older (22.7-45.5 kg): 75 mg/day
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
Adjust dosage to individual and the severity of condition, recognizing that the mg for mg 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 the 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.
Precautions
In general, dosage levels should be lower in the elderly, the emaciated and the debilitated. Largactil 4% should be used cautiously in patients with cardiovascular, liver or renal disease.
Dialysis
Data not available
Other Comments
Largactil 4% should generally not be used in children under 6 months of age except where potentially lifesaving.
Alcohol, barbiturates and other sedatives may intensify the CNS depressant effects of Largactil 4% and respiratory depression may occur.
The hypotensive effect of most antihypertensive agents, especially alpha-adrenoceptor blocking agents, may be exaggerated by Largactil 4%.
Largactil 4% has mild anticholinergic activity which may be enhanced by other anticholinergic drugs.
Anticholinergic drugs may decrease the antipsychotic effect of Largactil 4%. Largactil 4% 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, Largactil 4% 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 Largactil 4%. 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 Largactil 4% 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 Largactil 4%. A premonitory sign may be sudden onset of fever after 1-3 weeks of treatment followed by the development of jaundice. Largactil 4% 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 Largactil 4%. The greatest care must be taken to avoid contact of Largactil 4% with the skin. Skin rashes of various kinds may also be seen in patients treated with Largactil 4%. 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.
Largactil 4% is not for use in psychotic conditions related to dementia. Largactil 4% may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.
Do not use Largactil 4% 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 Largactil 4% or other phenothiazines.
Before you take Largactil 4%, 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 Largactil 4% or similar medicines.
Before taking Largactil 4%, tell your doctor about all other medications you use.
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).
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