Drug Interaction:
CNS Stimulants - Analeptics include-
Caffeine citrate, Doxapram Hcl, Modanafinil, Armodafinil
Interacting drugs- Summary
Cimetidine / contraceptives oral/ fluroquinolone/ciprofloxacin/enoxacin+ Caffeine
caffeine metabolism impaired
Phenylpropanolamine + caffeine
serum caffeine increased
Smoking + Caffeine
eliimination of caffeine enhanced
Mexilitine + caffeine
Caffeine clearance decreased with caffeine
Drug/Lab test interactions: Caffeine produces false positive serum urate as measured by the Bittner method. Caffeine also produces slight increases in urine levels of VMA, catecholamines and 5-hydroxyindoleacetic acid.
Avoid caffeine intake during these tests.
Indication:
As an aid in staying awake and restoring mental alertness.
CNS Stimulants - Analeptics include- Caffeine citrate, Doxapram Hcl, Modanafinil, Armodafinil
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1.Caffeine citrate 20mg/ml 18-07-2009
(equv. to 10mg of caffeine base)
oral solution
Addl.Dosage Form
2. Cafeine citrate 10mg/ml injection 16-05-2009
For the short term treatment of apnoea of prematurity of infants
between 28 and <33 weeks gestational age
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Caffeine 100mg+ March 1976
Ergommetine tartrate 1mg+
Analgin 250mg+
Trifluperazine Hcl 1mg Capsule
Adverse Reaction:
CNS-
Insomnia, restlessness, excitement, nervousness, tinnitus, scintilating scotoma, muscular tremor, headaches, lightheadedness.
Large doses of caffeine may produce symptoms mimicking anxiety neurosis. muscle twiching
GI-
nausea,vomiting, diarrhoea, stomach pain.
Cardiovascular-
tachycardia, extrasystoles, palpitations.
Withdrawal -
headache,anxiety and muscle tension may occur following abrupt cessation of drug after consumption of 500 to 600 mg/day.
Contra-Indications:
Reports not available
Special precautions
: Higher blood glucose levels may result from caffeine use. Hyperglycemic efects- higher blood glucose levels may result from caffeine use.
Warnings
Depression- too vigorous treatment with parenntral caffeine can produce further depression in the alreadt depressed patient, therfore do not exceed 1g as a single dose of caffeine and sodium benzoate.
GI- large quantities of caffeine containing products may reactivate duodenal ulcers.
Pregnancy- safety for use during pregnancy has not been established.
Lactation- cafeine apperars in the breast milk of nursing mothers. Use with caution.
Dosages/ Overdosage Etc:
Date of Approval 1976
Indications:
As an aid in staying awake and restoring mental alertness.
Dosage: Oral- 100 to 200mg every 3 to 4 hours,as needed. Not recommended for children Time release- 200mg every 3 to 4 hours.
Overdosage- Symptoms Toxic symptoms can be produced in the adult with 1 g oral caffeine. Deaths have ocured after IVand oral administration of caffeine and rectal administration of coffee. The acute lethal dose of caffeine ranges from from 5 to 10 g IV or oral.
Adults- Initially insomina, dyspnea, mild delirium. Alternating states of consciousness and muscle twitching may appear. Diuresis, arrhythmias and hyperglycemia have occured. The terminal event is usually seizures.
Infants- Caffeine overdosage has been reported in newborns given a single dose of caffeine 36 to 94 mg/kg at birth. Symptoms included hypertonicity alternating with hypotonicity, opioshotonic posturing, coarse tremors ,braycardia,hypotension and severe acidosis. Intracranial hemorrhage has also occured.
Treatment
1. Symptomatic and supportive.
2. Gastric lavage folowed by activated charcoal may be useful
3. Control seizures with diazepam or phenobarbital.
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Patient Information:
CNS Stimulants - Analeptics include-
Caffeine citrate, Doxapram Hcl, Modanafinil, Armodafinil
CAFFEINE-
1. Do not exceed the recommended dosage.
2. Discontinue use if increased or abnormal heart rate, dizziness or palpitations occur.
3. If fatigue persists or recurs,consult physician.
4. Not intended for use as a substitute for normal sleep.
5. Allergy- Tell your doctor about any unusual reaction to amiophylline, caffeine, dyphylline, oxtripphylline, theobromine or teophylline, and also to any food substances, preservative, dyestuffs etc.
6. Pregnancy- Studies in humans have shown that caffeine may cause miscarriage or may slow the growth of a developing fetus when given in doses greater than 300mg a day. In addition use of large amounts of caffeine by the mother during pregnancy may cause problems with heart rhythm of the fetus. Recommed that pregnant women consume less than 300mg of caffeine ( a amount equal to 3 cups of of coffee)
7. Breast feeding- Caffeine passes into breast milk in small amounts and may build up in nursing baby. Babies may be jittery and have trouble in sleeping when their mothers drink large amounts of caffeine containing products.
8. Children- With exception of children, no specific information comparing use of caffeine in children with use in other age groups
9. Other medicines- Tell your doctor if you are taking any other medicines- Amantadine or Amphetamie or Appetite stimulants or Chlophenidianol or Cocaine or Medicine for asthma or Medicine for cold ,sinus problems, hay fever, or other allergies Methylphenidate or Nabilone or Other medicines or beverages containing caffeine or Pemoline -using these medicines with caffeine may increase the CNS stimulant effects , such as nervousness, irritabilitry, or trouble in sleeping, or possibly cause convulsions or changes in rhythm of your heart MAO inhibitors-
10. Other medical problems- Make sure your doctor knows if you have any other medical problems- Agoraphobia ( fear of being in open places) or Anxiety or High blood pressure or Panic attacks or Trouble in sleeping - caffeine may make the condition worse Liver disease - higher blood levels of caffeine may result , increasing chance of side effects.
11. Missed dose - If you miss a dose of this medicine, take it as soon as possible. however, if it is almost time for the next dose, skip the missed dose. Do not double doses.
12. Storage - Keep out of reach of children. Store away from heat or direct sunlight. Do not store the capsule in bathroom, near the kitchen sink, or in other damp places.
13. Outdated medicines - Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of reach of children.
Pharmacology/ Pharmacokinetics:
CNS Stimulants - Analeptics include-
Caffeine citrate, Doxapram Hcl, Modanafinil, Armodafinil
Pharmacology:
Caffeine a methylxanthine,exerts its pharmacological effects by increasing calcium permeability in sarcoplastic reticulam. It is a potent stimulant of CNS .It also produces cardiac stimulation, dilatation of coronary and peripheral blood vessels, constriction of cerebral blood vessels, skeletal muscle stimulation, augumentation of gastric secretion and diuretic activity.
Pharmacokinetics:
Caffeine is well absorbed orally. Plasma levels of 5 to 25 mcg/ml are acheieved in 15 to 45 minutes after 250 mg. Caffeine is metabolised in the liver and excreted unchanged in the urine.
Interaction with Food:
Coffee and tea consumption with a meal or 1 hour after a meal significantly inhibits the absorption of dietary iron.
Clinical significance has not been established.
Pregnancy and lactation:
Pregnancy:
Safety for use during pregnancy has not been established. Pregnant women should consume sparingly or avoid caffeine containing food and drugs.
Lactation- Caffeine appears in the breast milk of nursing mothers. Approximately 1.5mg or 3mg of caffeine would be injected by a nursing infant whose mother had one cup of coffee.