Drug Interaction:
Antineuoplastic agents include- Interferon ALFA 2a, Interferon ALFA -2b, Interferon ALFA -n3, Levamisole, Altretamine, Cladribine, Hydroxyurea, Aldesleukin, Paclitaxel, Docetaxel,Tretinion, Procarbazine,Dacarbazine, Gemcitabine, Mitotane, Asparaginase, Pegaspargase,Porfimer Sodium
Alcohol causes flushing,nausea,palpitation and headache.
Indication:
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Levamisole HCL IP 112.5mg eq. to Levamisole 95.45mg+ 07-08-2014
Oxyclozanide IP 150mg+
Anhydrous Copper Sulphate BP eq.to elem Copper 1.25mg +
Zinc Sulphate monohydrate USP eq.to elemental Zinc 0.4mg+
Cobalt sulphate eq.to elemental cobalt 0.15mg
(Veterniary Product)
For the control and treatment of Gastrointestinal and
Pulmonary Nematodes, liver Flukes and Amphistomes
2.Levamisole 1.5% + Sept-1984
Mebendazole 200mg tablet
3.Levimisole 1.5% + 29-09-1993
Oxyclozanide 3% suspn
For veterinary use
Antineuoplastic agents include- Interferon ALFA 2a, Interferon ALFA -2b, Interferon ALFA -n3, Levamisole, Altretamine, Cladribine, Hydroxyurea, Aldesleukin, Paclitaxel, Docetaxel,Tretinion, Procarbazine,Dacarbazine, Gemcitabine, Mitotane, Asparaginase, Pegaspargase,Porfimer Sodium
Adjuvant treatment in combination with fluorocil after surgical rescetion in patients with Dukes stage colon cancer.
Adverse Reaction:
Agranulocytosis. Nausea, vomiting, abdominal pain, dizziness, headache (when given in single dose for ascrriasis).
Persistent treatment- Fever, rash, nausea, taste and smell disturbances, GI symptoms, dizziness and cutaneous vasculitis.
Contra-Indications:
Hepatic disease, blood dyscrasias, hypertens, pregnancy.
Special precautions: Should not be adminstered simulateously with carbon tetrachloride, tetrachloroethylene, chloroform or ether. Rheumatoid arthritis.
Dosages/ Overdosage Etc:
Indications:
Adjuvant treatment in combination with fluorocil after surgical rescetion in patients with Dukes stage colon cancer.
Dosage:
Adjuvant use of levamisole with fluorocil Levamisole- initial- 5mg orally every 8 hours for 3 days (starting 7 to 30 days post surgery.
Fluorocil- 450mg/sqm/day IV for 5 days concomittant with a 3 day course of Levamisole (starting 21 to 34 days post-surgery)
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
Levamisole. Also tell your healthcare care professional if you are allergic to
any other medicines
2.Pregnancy-
Studies have not been done in humans. However, studies in rats and rabbits, have
not shown to cause birth defects or other problems
3. Breast-feeding-
It is known whether Levamisole passes into breast milk. However, this medicine
has not reported to cause problems in nursing babies
4.Children-
Studies of this medicine has been done only in adult patients and there is no specific
information comparing Levamisole in children with use in other age groups.
5.Older adults-
There is no specific information comparing use of Levamisole in the elderly
with use in other age groups , however, it is not expected to cause different
problems in elderly than it does in younger adults
6. Other medicines-
Tell your doctor if you taking any other prescribtion or non- prescribiption medicines
7. Other medical problems-
The presence of other medical problems may affect the use of Levamisole.
Make sure you tell your doctor if you have any other medical problems
especially-
Infection - Levamisole may decrease your bodys ability to fight infection.
Pharmacology/ Pharmacokinetics:
Pharmacology: Levamisole is an immunomodulator. The mechanism of action of levamisole with fluorocil is unknown. The drug appears to restore depressed immune function rather than to stimulate response to above normal levels.
Pharmacokinetics:
It appears levamisole is rapidly absorbed from the G I tract. Mean plasma concentrations of 0.13mcg/ml are attained between 3 to 4 hours.
The elimination half-life of metabolite excretion is 16 hours.
Interaction with Food:
None reported
Pregnancy and lactation:
Pregnancy:
Do not administer Levamisole unless the potential benefits outweigh the risks.
Lactation:
Not known whether levamisole is excreted in breast milk. Weigh potential benefits against the potential hazard to the nursing infants, before administration to a nursing mother
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