Friday 3 February 2012

MORPHINE (Generic)

Drug Profile
2. Brand(s):
Brand Name
Manufacturer
Dosage Form
Pack Size
MRP
Morphine sulphate

Injection



3. Pharmacological Group:
                                                      Narcotic pain relievers.
4. Formulation:
                                 Ampoule (0.5-50mg/ml of morphine)
5. General Information:
 Morphine is a highly addictive substance, both psychologically and physically.   tolerance, physical and psychological dependences develop very rapidly:
6. Dosage Form:
Solids
Tablets
Capsules
Hard Capsules
Soft Capsules
Modified Released Capsules
Uncoated Tablets
Coated Tablets
Modified Released Tablets
Sublingual Tablets
Powders
Powders for suspension
Powders for Inhalers
Others


Liquids

Syrup
Oral drops
Nasal Drops
Topical Solutions
Eye Preparations
Ear Preparations
Others

Parenterals Preparations
Injection
Infusions
Powders for injection
Others

Topical Solids
Ointment
Creams
lotions
Gels
Pastes
Others

6. Therapeutic Uses:
 Morphine is used legally:
7. Information for the user:
i. How to take:
Use this medication exactly as it was prescribed for you. Never take morphine in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label

ii. Frequency & Time of Doses:
                                                      8-20 mg IM bd
iii. Recommended Dosage Range:
Neonates/ Children
Adult
Geriatric
Dose according to clinical condition
Oral 0.3 mg/kg q 3-4 hrs
Parenterals 0.1mg/kg q 3-4 hrs
Oral 30mg q 3-4 hrs
Parentrals 10mg 3-4 hrs



iv. Onset of effect:
                                 60 min
v. duration of action
                               60-90 min
vi. Diet Advice:
                           Drink plenty of fluids while you are taking this medication
vii. Storage:
Store this medication at room temperature, away from heat, moisture, and light. Keep track of how many pills have been used from each new bottle of this medicine. .After you have stopped using this medication, flush any unused pills down the toilet. Throw away any unused liquid morphine that is older than 90 days.
viii: Missed Dose:
Since morphine is sometimes used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.



ix. Stopping the drug:
Do not stop using morphine suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
x. Exceeding the dose (overdose):
Seek emergency medical attention if you think you have used too much of this medicine. An overdose of morphine can be fatal. Overdose symptoms may include extreme drowsiness, pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.
8. Possible Adverse Effects:
·         shallow breathing, slow heartbeat;
·         seizure (convulsions);
·         cold, clammy skin;
·         confusion;
·         severe weakness or dizziness; or
  • feeling light-headed, fainting.
  • upset stomach
  • vomiting
  • constipation
  • stomach pain
  • rash
  • difficulty urinating
9. Contraindications:
Hypersensitivity to morphine
Respiratory and CNS depression with respiratory failure
Suspected head injury it may cause exaggerated CNS depression





10. Interactions:
Drug-Drug Interactions
Drug-Food Interactions

MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil)
other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing.
Check your food and medicine labels to be sure these products do not contain alcohol
11. Prolonged Use:
                                      Results in the addiction
12. Special Precautions:
 i. Be sure to tell your doctor if:
if you are using pentazocine (Talwin), nalbuphine (Nubain), butorphanol (Stadol), or buprenorphine (Buprenex, Subutex). If you are using any of these drugs, you may not be able to use morphine, or you may need dosage adjustments or special tests during treatment. if you have ever had an allergic reaction to a narcotic medicine (examples include codeine, methado),asthma attack a history of head injury or brain tumor;  epilepsy or other seizure disorder; low blood pressure; gallbladder disease; Addison's disease or other adrenal gland disorders; enlarged prostate, urination problems; a history of drug or alcohol addiction
ii. Pregnancy:
                        Morphine diffuses across the placenta
iii. Breast Feeding/Lactation:
Traces appear in breast milk It may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

iv. Infants & Children:
                                       Same pharmacological effect as in adult
v. Over 60:
Older adults may be more sensitive to the effects of this medicine.
vi. Driving & Hazardous work:
                                                       Impair thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
 vii. Alcohol:
                       Do not drink alcohol while you are taking this medication. Dangerous side effects or death can occur when alcohol is combined with morphine
13. Pharmacological Properties:
13.(i). Pharmacodynamic Properties:
It binds to specific .G protein –coupled receptor ,located primarily in brain and spinal cord regions involved in the transmission  and modulation of pain.
13.(ii). Pharmacokinetic Properties:
i. Absorption:
                         Well absorbed in GIT
ii. Distribution:
Bioavailability
%Protein binding
Half Life
Volume of distribution
Blood Brain Barrier
Placental Barrier
Oral 25%
I M 100%
35%
2-3 hrs
3.3 L/kg
poorly
crosses
iii. Metabolism
Site of Metabolism
Active Metabolites
Liver and Gut
Morphine-3-glucuronide, Morphine-6-glcrounide,nor morphine, codiene

iv. Elimination:
Elimination Half Life
Route of Elimination
                           1.7 hrs
10% through feaces 90% through urine

15. Preclinical Safety Data:
                                                      In biphasic cortisole response also has been observed for narcotics. Morphine administered to rats is known to block the release of cortisole in response to histamine challenge by inhibiting release of ACTH.s
16. Instructions for Handling:
Keep track of how many pills have been used from each new bottle of this medicine. Morphine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

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