Oblant may be available in the countries listed below.
Ingredient matches for Oblant
Cinnarizine is reported as an ingredient of Oblant in the following countries:
- Mexico
International Drug Name Search
Oblant may be available in the countries listed below.
Cinnarizine is reported as an ingredient of Oblant in the following countries:
International Drug Name Search
Celestoderm-V with Garamycin may be available in the countries listed below.
Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Celestoderm-V with Garamycin in the following countries:
Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Celestoderm-V with Garamycin in the following countries:
International Drug Name Search
Urizone may be available in the countries listed below.
Fosfomycin tromethamine (a derivative of Fosfomycin) is reported as an ingredient of Urizone in the following countries:
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Diacarb may be available in the countries listed below.
Acetazolamide is reported as an ingredient of Diacarb in the following countries:
International Drug Name Search
Mesopil may be available in the countries listed below.
Misoprostol is reported as an ingredient of Mesopil in the following countries:
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Unifyl retard may be available in the countries listed below.
Theophylline is reported as an ingredient of Unifyl retard in the following countries:
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Disopyran may be available in the countries listed below.
Disopyramide is reported as an ingredient of Disopyran in the following countries:
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Estradiol Valerianato L.CH. may be available in the countries listed below.
Estradiol 17ß-valerate (a derivative of Estradiol) is reported as an ingredient of Estradiol Valerianato L.CH. in the following countries:
International Drug Name Search
Orgamox may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Orgamox in the following countries:
International Drug Name Search
Azitromicina Qualigen may be available in the countries listed below.
Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Azitromicina Qualigen in the following countries:
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Ulgixal may be available in the countries listed below.
Pemirolast potassium salt (a derivative of Pemirolast) is reported as an ingredient of Ulgixal in the following countries:
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Generic Name: rifampin (rif AM pin)
Brand names: Rifadin, Rimactane, Rifadin IV
Rifampin is an antibiotic. Rifampin prevents bacteria from spreading in your body.
Rifampin is used to treat or prevent tuberculosis (TB).
Rifampin may also be used to eliminate a bacteria from your nose and throat that may cause meningitis or other infections, even if you do not have an infection. Rifampin prevents you from spreading this bacteria to other people, but the medication will not treat an infection caused by the bacteria.
Rifampin may also be used for other purposes not listed in this medication guide.
Before taking rifampin, tell your doctor if you are allergic to any drugs, or if you have liver disease or porphyria ( (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).
Do not wear contact lenses while you are taking rifampin. This medicine may discolor your tears, which could permanently stain soft contact lenses.
Before taking rifampin, tell your doctor if you are allergic to any drugs, or if you have:
liver disease; or
porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).
If you have any of these conditions, you may need a dose adjustment or special tests to safely take rifampin.
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Take the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up a missed dose.
Overdose symptoms may include nausea, vomiting, itching, headache, weakness, fast or uneven heart rate, or feeling like you might pass out.
Do not wear contact lenses while you are taking rifampin. This medicine may discolor your tears, which could permanently stain soft contact lenses.
fever, chills, body aches, flu symptoms;
joint pain or swelling;
easy bruising or bleeding, weakness;
urinating less than usual or not at all; or
nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
tired feeling; or
red or orange colored urine, stools, tears, sweat, or saliva.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Tuberculosis -- Active:
The manufacturer recommends: 10 mg/kg (not to exceed 600 mg) orally or IV once a day
The American Thoracic Society (ATS), Centers for Disease Control and Prevention (CDC), and Infectious Diseases Society of America (IDSA) recommend:
Daily regimen: 10 mg/kg (up to 600 mg/day) orally or IV once a day
Intermittent regimen: 10 mg/kg (up to 600 mg/dose) orally or IV 2 or 3 times a week
A three-drug regimen consisting of isoniazid, rifampin, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. Treatment should then be continued with isoniazid and rifampin for at least 4 months. Treatment duration should be extended if the patient's sputum or culture remains positive, if resistant organisms are present, or if the patient is HIV positive.
The Advisory Council for the Elimination of Tuberculosis, the ATS, and the CDC recommend adding streptomycin or ethambutol as a fourth drug in a regimen including isoniazid, pyrazinamide, and rifampin for initial treatment of tuberculosis unless the probability of isoniazid or rifampin resistance is very low. The need for a fourth drug should be reevaluated when susceptibility test results are known. If current community rates of isoniazid resistance are less than 4%, initial treatment with less than 4 drugs may be considered.
Usual Adult Dose for Tuberculosis -- Latent:
Patients with a positive tuberculin test without evidence of disease: 10 mg/kg (not to exceed 600 mg) orally or IV once a day for 4 months
While isoniazid monotherapy is usually sufficient for treatment with a positive tuberculin skin test and no signs of disease, rifampin may be used if isoniazid resistance is suspected or if isoniazid is not tolerated.
Usual Adult Dose for Meningococcal Meningitis Prophylaxis:
Treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx: 600 mg orally or IV twice a day for 2 days
Usual Adult Dose for Haemophilus influenzae Prophylaxis:
600 mg orally or IV once a day for 4 consecutive days
Usual Adult Dose for Endocarditis:
300 mg orally or IV every 8 hours for 6 weeks
Used concomitantly with nafcillin or vancomycin for the treatment of endocarditis in the presence of prosthetic material. Gentamicin is often added for the first 2 weeks of therapy.
Usual Adult Dose for Legionella Pneumonia:
600 mg orally or IV once a day for 14 days
May be added to erythromycin therapy
Usual Adult Dose for Nasal Carriage of Staphylococcus aureus:
600 mg orally or IV twice a day for 5 days for the treatment of chronic carriage of Staphylococcus aureus
Rifampin monotherapy or rifampin plus penicillin has been shown to eradicate staphylococci and Streptococcus pyogenes nasal colonization in nearly all cases.
Usual Adult Dose for Meningitis:
Caused by Streptococcus pneumoniae: 600 mg orally or IV once a day for 10 to 14 days, in patients with severe penicillin allergy needing empiric or specific coverage
Sometimes used as adjunctive therapy for penicillin-resistant (MIC greater than or equal to 2.0 mcg/mL) meningitis. Regimen consists of vancomycin IV and rifampin. In addition, rifampin is sometimes used as adjunctive therapy to vancomycin in patients with infected CSF shunts.
Usual Adult Dose for Leprosy -- Tuberculoid:
Paucibacillary (tuberculid or indeterminate): 600 mg orally once a month, plus dapsone 100 mg daily, for a total of 6 months of therapy
Usual Adult Dose for Leprosy -- Borderline:
Multibacillary (lepromatous or borderline): 600 mg orally once a month along with clofazimine, plus daily dapsone and clofazimine, for a total of 12 months of therapy
Usual Pediatric Dose for Meningococcal Meningitis Prophylaxis:
Treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx:
Less than 1 month: 5 mg/kg orally or IV every 12 hours for 2 days
1 month or older: 10 mg/kg (not to exceed 600 mg/dose) orally or IV every 12 hours for 2 days
Usual Pediatric Dose for Tuberculosis -- Active:
For pediatric patients, the manufacturer recommends: 10 to 20 mg/kg/day (not to exceed 600 mg/day) orally or IV
For patients less than 15 years, the ATS, CDC, IDSA, and American Academy of Pediatrics (AAP) recommend:
Daily regimen: 10 to 20 mg/kg/day (up to 600 mg/day) orally or IV
Intermittent regimen: 10 to 20 mg/kg (up to 600 mg/dose) orally or IV twice a week
For patients 15 years or older, the ATS, CDC, and IDSA recommend:
Daily regimen: 10 mg/kg (up to 600 mg/day) orally or IV once a day
Intermittent regimen: 10 mg/kg (up to 600 mg/dose) orally or IV 2 or 3 times a week
A three-drug regimen consisting of isoniazid, rifampin, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. Treatment should then be continued with isoniazid and rifampin for at least 4 months. Treatment duration should be extended if the patient's sputum or culture remains positive, if resistant organisms are present, or if the patient is HIV positive.
The Advisory Council for the Elimination of Tuberculosis, the ATS, and the CDC recommend adding streptomycin or ethambutol as a fourth drug in a regimen including isoniazid, pyrazinamide, and rifampin for initial treatment of tuberculosis unless the probability of isoniazid or rifampin resistance is very low. The need for a fourth drug should be reevaluated when susceptibility test results are known. If current community rates of isoniazid resistance are less than 4%, initial treatment with less than 4 drugs may be considered.
Study (n=175)
Directly Observed Therapy (DOT) - Two weeks daily therapy:
Greater than 1 month:
Weeks 1 and 2: Daily dosing of rifampin 10 to 20 mg/kg/day, isoniazid 10 to 15 mg/kg/day, and pyrazinamide 20 to 40 mg/kg/day
Weeks 3 to 8: Twice weekly rifampin 10 to 20 mg/kg/dose, isoniazid 20 to 40 mg/kg/dose, and pyrazinamide 50 to 70 mg/kg/dose
Weeks 9 to 24: Twice weekly rifampin 10 to 20 mg/kg/dose and isoniazid 20 to 40 mg/kg/dose
Usual Pediatric Dose for Tuberculosis -- Latent:
Infants, children, and adolescents:
The ATS, CDC, and AAP recommend: 10 to 20 mg/kg/day (up to 600 mg/day) orally or IV for 4 to 6 months
Many drugs can interact with rifampin. Below is just a partial list. Tell your doctor if you are using:
acetaminophen (Tylenol);
a blood thinner such as warfarin (Coumadin);
a barbiturate such as phenobarbital (Solfoton);
diazepam (Valium) or similar medicines such as alprazolam (Xanax), chlordiazepoxide (Librium), midazolam (Versed), temazepam (Restoril), triazolam (Halcion), and others;
a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta, Ziac), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), timolol (Blocadren), and others;
clofibrate (Atromid-S);
steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others;
birth control pills or estrogen hormone replacement;
heart medicines such as digoxin (Lanoxin), disopyramide (Norpace), quinidine (Quinaglute, Quinidex), mexiletine (Mexitil), tocainide (Tonocard), verapamil (Calan, Verelan, Isoptin), or enalapril (Vasotec);
HIV medicines such as delavirdine (Rescriptor), saquinavir (Invirase, Fortovase), ritonavir (Norvir), nelfinavir (Viracept), and others;
ketoconazole (Nizoral), itraconazole (Sporanox), or fluconazole (Diflucan);
methadone (Dolophine);
phenytoin (Dilantin), ethotoin (Peganone), and mephenytoin (Mesantoin);
sulfa drugs (Bactrim, Gantanol, Septra, and others);
diabetes medication you take by mouth;
cyclosporine (Sandimmune, Neoral); or
theophylline (Elixophyllin, TheoCap, Theochron, Uniphyl).
See also: rifampin side effects (in more detail)
In the US, Gastromark (ferumoxsil systemic) is a member of the drug class magnetic resonance imaging contrast media.
US matches:
Ferumoxsil is reported as an ingredient of Gastromark in the following countries:
International Drug Name Search
Dominal forte may be available in the countries listed below.
Prothipendyl hydrochloride (a derivative of Prothipendyl) is reported as an ingredient of Dominal forte in the following countries:
International Drug Name Search
Dismolan may be available in the countries listed below.
Ondansetron is reported as an ingredient of Dismolan in the following countries:
Ondansetron hydrochloride (a derivative of Ondansetron) is reported as an ingredient of Dismolan in the following countries:
International Drug Name Search
Risperidon-ratiopharm may be available in the countries listed below.
Risperidone is reported as an ingredient of Risperidon-ratiopharm in the following countries:
International Drug Name Search
Ciplabutol may be available in the countries listed below.
Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Ciplabutol in the following countries:
International Drug Name Search
Clavinex may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Clavinex in the following countries:
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Clavinex in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Clavinex in the following countries:
International Drug Name Search
Propylhexédrine may be available in the countries listed below.
Propylhexédrine (DCF) is known as Propylhexedrine in the US.
International Drug Name Search
Glossary
DCF | Dénomination Commune Française |
In some countries, this medicine may only be approved for veterinary use.
In the US, Stanozolol (stanozolol systemic) is a member of the drug class androgens and anabolic steroids and is used to treat Angioedema.
US matches:
Rec.INN
A14AA02
0010418-03-8
C21-H32-N2-O
328
Anabolic
Androgen
2'H-Androst-2-eno[3,2-c]pyrazol-17-ol, 17-methyl-, (5α,17ß)-
International Drug Name Search
Glossary
BAN | British Approved Name |
DCF | Dénomination Commune Française |
DCIT | Denominazione Comune Italiana |
IS | Inofficial Synonym |
JAN | Japanese Accepted Name |
OS | Official Synonym |
PH | Pharmacopoeia Name |
Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
USAN | United States Adopted Name |
Risdonal may be available in the countries listed below.
Risperidone is reported as an ingredient of Risdonal in the following countries:
International Drug Name Search
In the US, Venofer (iron sucrose systemic) is a member of the drug class iron products and is used to treat Iron Deficiency Anemia.
US matches:
UK matches:
Iron Sucrose is reported as an ingredient of Venofer in the following countries:
International Drug Name Search
Glossary
SPC | Summary of Product Characteristics (UK) |
In the US, Dexamethasone Intensol (dexamethasone systemic) is a member of the drug class glucocorticoids and is used to treat Addison's Disease, Adrenal Insufficiency, Adrenocortical Insufficiency, Adrenogenital Syndrome, Ankylosing Spondylitis, Aspiration Pneumonia, Asthma, Asthma - acute, Atopic Dermatitis, Bursitis, Cerebral Edema, Chorioretinitis, Croup, Cushing's Syndrome, Dermatitis Herpetiformis, Eczema, Epicondylitis - Tennis Elbow, Erythroblastopenia, Evan's Syndrome, Gouty Arthritis, Hay Fever, Hemolytic Anemia, Hypercalcemia of Malignancy, Idiopathic Thrombocytopenic Purpura, Inflammatory Conditions, Iridocyclitis, Iritis, Juvenile Rheumatoid Arthritis, Keratitis, Leukemia, Loeffler's Syndrome, Lymphoma, Meningitis - Haemophilus influenzae, Meningitis - Listeriosis, Meningitis - Meningococcal, Meningitis - Pneumococcal, Multiple Myeloma, Multiple Sclerosis, Mycosis Fungoides, Nausea/Vomiting - Chemotherapy Induced, Neurosarcoidosis, Pemphigus, Psoriatic Arthritis, Pulmonary Tuberculosis, Rheumatoid Arthritis, Sarcoidosis, Seborrheic Dermatitis, Shock, Synovitis, Systemic Lupus Erythematosus, Thrombocytopenia, Toxic Epidermal Necrolysis, Tuberculous Meningitis, Ulcerative Colitis and Uveitis - Posterior.
US matches:
Dexamethasone is reported as an ingredient of Dexamethasone Intensol in the following countries:
International Drug Name Search
Mannitol Maco Pharma may be available in the countries listed below.
Mannitol is reported as an ingredient of Mannitol Maco Pharma in the following countries:
International Drug Name Search
Dentacilina may be available in the countries listed below.
Ampicillin is reported as an ingredient of Dentacilina in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
In the US, Codeine (codeine systemic) is a member of the following drug classes: antitussives, narcotic analgesics and is used to treat Cough, Diarrhea and Pain.
US matches:
UK matches:
BAN
R05DA04
0000076-57-3
C18-H21-N-O3
299
Cough suppressant
Opioid analgesic
Morphin-7-en-6α-ol, 4,5α-epoxy-3-methoxy-17-methyl-,
Morphinan-6-ol, 7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-, (5α,6α)-
International Drug Name Search
Glossary
BAN | British Approved Name |
BANM | British Approved Name (Modified) |
DCF | Dénomination Commune Française |
IS | Inofficial Synonym |
JAN | Japanese Accepted Name |
OS | Official Synonym |
PH | Pharmacopoeia Name |
SPC | Summary of Product Characteristics (UK) |
USAN | United States Adopted Name |
Bexon may be available in the countries listed below.
Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Bexon in the following countries:
Metronidazole benzoate (a derivative of Metronidazole) is reported as an ingredient of Bexon in the following countries:
International Drug Name Search
In the US, Zolpimist (zolpidem systemic) is a member of the drug class miscellaneous anxiolytics, sedatives and hypnotics and is used to treat Insomnia.
US matches:
Zolpidem tartrate (a derivative of Zolpidem) is reported as an ingredient of Zolpimist in the following countries:
International Drug Name Search
Atropina Braun may be available in the countries listed below.
Atropine sulfate (a derivative of Atropine) is reported as an ingredient of Atropina Braun in the following countries:
International Drug Name Search
Each diphenoxylate hydrochloride and atropine sulfate tablet contains:
diphenoxylate hydrochloride | 2.5 mg |
atropine sulfate | 0.025 mg |
Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride and has the following structural formula:
Atropine sulfate, an anticholinergic, is endo-(±)-α-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate and has the following structural formula:
A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage.
Inactive ingredients of diphenoxylate hydrochloride tablets include acacia, corn starch, magnesium stearate, sorbitol, sucrose, and talc.
Diphenoxylate is rapidly and extensively metabolized in man by ester hydrolysis to diphenoxylic acid (difenoxine), which is biologically active and the major metabolite in the blood. After a 5-mg oral dose of carbon-14 labeled diphenoxylate hydrochloride in ethanolic solution was given to three healthy volunteers, an average of 14% of the drug plus its metabolites was excreted in the urine and 49% in the feces over a four-day period. Urinary excretion of the unmetabolized drug constituted less than 1% of the dose, and diphenoxylic acid plus its glucuronide conjugate constituted about 6% of the dose. In a 16-subject crossover bioavailability study, a linear relationship in the dose range of 2.5 to 10 mg was found between the dose of diphenoxylate hydrochloride (given as diphenoxylate hydrochloride liquid) and the peak plasma concentration, the area under the plasma concentration-time curve, and the amount of diphenoxylic acid excreted in the urine. In the same study the bioavailability of the tablet compared with an equal dose of the liquid was approximately 90%. The average peak plasma concentration of diphenoxylic acid following ingestion of four 2.5-mg tablets was 163 ng/ml at about 2 hours, and the elimination half-life of diphenoxylic acid was approximately 12 to 14 hours.
In dogs, diphenoxylate hydrochloride has a direct effect on circular smooth muscle of the bowel that conceivably results in segmentation and prolongation of gastrointestinal transit time. The clinical antidiarrheal action of diphenoxylate hydrochloride may thus be a consequence of enhanced segmentation that allows increased contact of the intraluminal contents with the intestinal mucosa.
Diphenoxylate hydrochloride is effective as adjunctive therapy in the management of diarrhea.
Diphenoxylate hydrochloride is contraindicated in patients with:
DIPHENOXYLATE HYDROCHLORIDE IS NOT AN INNOCUOUS DRUG AND DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO, ESPECIALLY IN CHILDREN. DIPHENOXYLATE HYDROCHLORIDE IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH (SEE OVERDOSAGE). THEREFORE, KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN.
THE USE OF DIPHENOXYLATE HYDROCHLORIDE SHOULD BE ACCOMPANIED BY APPROPRIATE FLUID AND ELECTROLYTE THERAPY, WHEN INDICATED. IF SEVERE DEHYDRATION OR ELECTROLYTE IMBALANCE IS PRESENT, DIPHENOXYLATE HYDROCHLORIDE SHOULD BE WITHHELD UNTIL APPROPRIATE CORRECTIVE THERAPY HAS BEEN INITIATED. DRUG-INDUCED INHIBITION OF PERISTALSIS MAY RESULT IN FLUID RETENTION IN THE INTESTINE, WHICH MAY FURTHER AGGRAVATE DEHYDRATION AND ELECTROLYTE IMBALANCE.
DIPHENOXYLATE HYDROCHLORIDE SHOULD BE USED WITH SPECIAL CAUTION IN YOUNG CHILDREN BECAUSE THIS AGE GROUP MAY BE PREDISPOSED TO DELAYED DIPHENOXYLATE TOXICITY AND BECAUSE OF THE GREATER VARIABILITY OF RESPONSE IN THIS AGE GROUP.
Antiperistaltic agents may prolong and/or worsen diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic E. coli, Salmonella, Shigella), and pseudomembranous enterocolitis associated with broad-spectrum antibiotics. Antiperistaltic agents should not be used in these conditions.
In some patients with acute ulcerative colitis, agents that inhibit intestinal motility or prolong intestinal transit time have been reported to induce toxic megacolon. Consequently, patients with acute ulcerative colitis should be carefully observed and diphenoxylate hydrochloride therapy should be discontinued promptly if abdominal distention occurs or if other untoward symptoms develop.
Since the chemical structure of diphenoxylate hydrochloride is similar to that of meperidine hydrochloride, the concurrent use of diphenoxylate hydrochloride with monoamine oxidase (MAO) inhibitors may, in theory, precipitate hypertensive crisis.
Diphenoxylate hydrochloride should be used with extreme caution in patients with advanced hepatorenal disease and in all patients with abnormal liver function since hepatic coma may be precipitated.
Diphenoxylate hydrochloride may potentiate the action of barbiturates, tranquilizers, and alcohol. Therefore, the patient should be closely observed when any of these are used concomitantly.
Since a subtherapeutic dose of atropine has been added to the diphenoxylate hydrochloride, consideration should be given to the precautions relating to the use of atropine. In children, diphenoxylate hydrochloride should be used with caution since signs of atropinism may occur even with recommended doses, particularly in patients with Down's syndrome.
INFORM THE PATIENT (PARENT OR GUARDIAN) NOT TO EXCEED THE RECOMMENDED DOSAGE AND TO KEEP DIPHENOXYLATE HYDROCHLORIDE OUT OF THE REACH OF CHILDREN AND IN A CHILD-RESISTANT CONTAINER. INFORM THE PATIENT OF THE CONSEQUENCES OF OVERDOSAGE, INCLUDING SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH. Diphenoxylate hydrochloride may produce drowsiness or dizziness. The patient should be cautioned regarding activities requiring mental alertness, such as driving or operating dangerous machinery. Potentiation of the action of alcohol, barbiturates, and tranquilizers with concomitant use of diphenoxylate hydrochloride should be explained to the patient. The physician should also provide the patient with other information in this labeling, as appropriate.
Known drug interactions include barbiturates, tranquilizers, and alcohol. Diphenoxylate hydrochloride may interact with MAO inhibitors (see Warnings).
In studies with male rats, diphenoxylate hydrochloride was found to inhibit the hepatic microsomal enzyme system at a dose of 2 mg/kg/day. Therefore, diphenoxylate has the potential to prolong the biological half-lives of drugs for which the rate of elimination is dependent on the microsomal drug metabolizing enzyme system.
No long-term study in animals has been performed to evaluate carcinogenic potential. Diphenoxylate hydrochloride was administered to male and female rats in their diets to provide dose levels of 4 and 20 mg/kg/day throughout a three-litter reproduction study. At 50 times the human dose (20 mg/kg/day), female weight gain was reduced and there was a marked effect on fertility as only 4 of 27 females became pregnant in three test breedings. The relevance of this finding to usage of diphenoxylate hydrochloride in humans is unknown.
Diphenoxylate hydrochloride has been shown to have an effect on fertility in rats when given in doses 50 times the human dose (see above discussion). Other findings in this study include a decrease in maternal weight gain of 30% at 20 mg/kg/day and of 10% at 4 mg/kg/day. At 10 times the human dose (4 mg/kg/day), average litter size was slightly reduced.
Teratology studies were conducted in rats, rabbits, and mice with diphenoxylate hydrochloride at oral doses of 0.4 to 20 mg/kg/day. Due to experimental design and small numbers of litters, embryotoxic, fetotoxic, or teratogenic effects cannot be adequately assessed. However, examination of the available fetuses did not reveal any indication of teratogenicity.
There are no adequate and well-controlled studies in pregnant women. Diphenoxylate hydrochloride should be used during pregnancy only if the anticipated benefit justifies the potential risk to the fetus.
Caution should be exercised when diphenoxylate hydrochloride is administered to a nursing woman, since the physicochemical characteristics of the major metabolite, diphenoxylic acid, are such that it may be excreted in breast milk and since it is known that atropine is excreted in breast milk.
Diphenoxylate hydrochloride may be used as an adjunct to the treatment of diarrhea but should be accompanied by appropriate fluid and electrolyte therapy, if needed. DIPHENOXYLATE HYDROCHLORIDE IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. Diphenoxylate hydrochloride should be used with special caution in young children because of the greater variability of response in this age group. See Warnings and Dosage and Administration. In case of accidental ingestion by children, see Overdosage for recommended treatment.
At therapeutic doses, the following have been reported; they are listed in decreasing order of severity, but not of frequency:
Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache.
Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus.
Gastrointestinal system: toxic megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort.
The following atropine sulfate effects are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes. These effects may occur, especially in children.
THIS MEDICATION SHOULD BE KEPT IN A CHILD-RESISTANT CONTAINER AND OUT OF THE REACH OF CHILDREN SINCE AN OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH.
Diphenoxylate hydrochloride is classified as a Schedule V controlled substance by federal regulation. Diphenoxylate hydrochloride is chemically related to the narcotic analgesic meperidine.
In doses used for the treatment of diarrhea, whether acute or chronic, diphenoxylate has not produced addiction.
Diphenoxylate hydrochloride is devoid of morphine-like subjective effects at therapeutic doses. At high doses it exhibits codeine-like subjective effects. The dose which produces antidiarrheal action is widely separated from the dose which causes central nervous system effects. The insolubility of diphenoxylate hydrochloride in commonly available aqueous media precludes intravenous self-administration. A dose of 100 to 300 mg/day, which is equivalent to 40 to 120 tablets, administered to humans for 40 to 70 days, produced opiate withdrawal symptoms. Since addiction to diphenoxylate hydrochloride is possible at high doses, the recommended dosage should not be exceeded.
RECOMMENDED DOSAGE SCHEDULES SHOULD BE STRICTLY FOLLOWED. THIS MEDICATION SHOULD BE KEPT IN A CHILD-RESISTANT CONTAINER AND OUT OF THE REACH OF CHILDREN, SINCE AN OVERDOSAGE MAY RESULT IN SEVERE, EVEN FATAL, RESPIRATORY DEPRESSION.
Initial signs of overdosage may include dryness of the skin and mucous membranes, mydriasis, restlessness, flushing, hyperthermia, and tachycardia followed by lethargy or coma, hypotonic reflexes, nystagmus, pinpoint pupils, and respiratory depression. Respiratory depression may be evidenced as late as 30 hours after ingestion and may recur despite an initial response to narcotic antagonists. TREAT ALL POSSIBLE DIPHENOXYLATE HYDROCHLORIDE OVERDOSAGES AS SERIOUS AND MAINTAIN MEDICAL OBSERVATION FOR AT LEAST 48 HOURS, PREFERABLY UNDER CONTINUOUS HOSPITAL CARE.
In the event of overdose, induction of vomiting, gastric lavage, establishment of a patent airway, and possibly mechanically assisted respiration are advised. In vitro and animal studies indicate that activated charcoal may significantly decrease the bioavailability of diphenoxylate. In noncomatose patients, a slurry of 100 g of activated charcoal can be administered immediately after the induction of vomiting or gastric lavage.
A pure narcotic antagonist (e.g., naloxone) should be used in the treatment of respiratory depression caused by diphenoxylate hydrochloride . When a narcotic antagonist is administered intravenously, the onset of action is generally apparent within two minutes. It may also be administered subcutaneously or intramuscularly, providing a slightly less rapid onset of action but a more prolonged effect.
To counteract respiratory depression caused by diphenoxylate hydrochloride overdosage, the following dosage schedule for the narcotic antagonist naloxone hydrochloride should be followed:
An initial dose of 0.4 mg to 2 mg of naloxone hydrochloride may be administered intravenously. If the desired degree of counteraction and improvement in respiratory functions is not obtained, it may be repeated at 2- to 3-minute intervals. If no response is observed after 10 mg of naloxone hydrochloride has been administered, the diagnosis of narcotic-induced or partial narcotic-induced toxicity should be questioned. Intramuscular or subcutaneous administration may be necessary if the intravenous route is not available.
The usual initial dose in children is 0.01 mg/kg body weight given I.V. If this dose does not result in the desired degree of clinical improvement, a subsequent dose of 0.1 mg/kg body weight may be administered. If an I.V. route of administration is not available, naloxone hydrochloride may be administered I.M. or S.C. in divided doses. If necessary, naloxone hydrochloride can be diluted with sterile water for injection.
Following initial improvement of respiratory function, repeated doses of naloxone hydrochloride may be required to counteract recurrent respiratory depression. Supplemental intramuscular doses of naloxone hydrochloride may be utilized to produce a longer-lasting effect.
Since the duration of action of diphenoxylate hydrochloride is longer than that of naloxone hydrochloride, improvement of respiration following administration may be followed by recurrent respiratory depression. Consequently, continuous observation is necessary until the effect of diphenoxylate hydrochloride on respiration has passed. This effect may persist for many hours. The period of observation should extend over at least 48 hours, preferably under continuous hospital care. Although signs of overdosage and respiratory depression may not be evident soon after ingestion of diphenoxylate hydrochloride, respiratory depression may occur from 12 to 30 hours later.
DO NOT EXCEED RECOMMENDED DOSAGE.
The recommended initial dosage is two diphenoxylate hydrochloride tablets four times daily . Most patients will require this dosage until initial control has been achieved, after which the dosage may be reduced to meet individual requirements. Control may often be maintained with as little as 5 mg (two tablets) daily.
Clinical improvement of acute diarrhea is usually observed within 48 hours. If clinical improvement of chronic diarrhea after treatment with a maximum daily dose of 20 mg of diphenoxylate hydrochloride is not observed within 10 days, symptoms are unlikely to be controlled by further administration.
Diphenoxylate hydrochloride is not recommended in children under 2 years of age and should be used with special caution in young children (see Warnings and Precautions). The nutritional status and degree of dehydration must be considered. Do not use diphenoxylate hydrochloride tablets for children under 13 years of age .
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Tablets — round, white, with SEARLE debossed on one side and 61 on the other side and containing 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate, supplied as:
NDC Number | Size |
---|---|
59762-1061-1 | bottle of 100 |
LAB-0517-1.0
June 2011
NDC 59762-1061-1
100 Tablets
GREENSTONE® BRAND
diphenoxylate
hydrochloride
and atropine
sulfate tablets,
USP
CV
2.5 mg/0.025 mg*
Rx only
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE diphenoxylate hydrochloride and atropine sulfate tablet | ||||||||||||||||||||
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
NDA authorized generic | NDA012462 | 09/15/1960 |
Labeler - Greenstone LLC (825560733) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Pfizer Pharmaceuticals LLC | 193684656 | MANUFACTURE |
Establishment | |||
Name | Address | ID/FEI | Operations |
Mallinckrodt Inc. Pharmaceuticals Group | 163205300 | API MANUFACTURE |