17. IMMUNOLOGICALS                                                                                 
                          HUMAN ANTI-D IMMUNOGLOBULIN  

General Information

 

Drug code                   Preparation                                         Strength

       305                       Human anti-D immunoglobulin   350 IU

 

Description of the Drug

Anti – D immunoglobulin is liquid or freeze-dried preparation contain immunoglobulin mainly IgG. It is obtained from plasma or serum of D – negative donors who have been immunized against the rhesus D antigen.

 

Mode of Action

It contains specific antibodies against the rhesus D antigen of human red blood cells. The immunolgobulin prevents the Rh positive fetal cells from triggering off the immune response of the unsensitized Rh negative mother against the ‘D’ antigen.

 

Pharmacokinetics:

When administered IM, it is absorbed slowly from the injection site. Plasma half-life of IgG immunoglobulin is about 23 – 26 days. 300 gms is capable of neutralizing the antigentic potential of upto 30 ml fetal blood (about 15 ml of fetal cells) and prevents Rh immunization in 90% of cases.

 

Clinical Information

 

Indications

It is administered to the Rh negative mother whenever there is possibility of  feto-mernal haemorrhage:

·    With in 72 hours of delivery of a Rh positive infant.

·    Antenaltally at 28 weeks of gestation, prophylactically.

·    Absorption – spontaneous or induced.

·    After amniocentesis.

·    External cephalic version.

·    Abdominal wall trauma.

·    Other means of sensitization –unmatched red cell transfusion.

Others : treatment of idiopathic thromobocytopenic purpura.

 

Dosage:

            After delivery: 1500 IU = 300 microgram, I.M.

After induced or spontaneous abortions: 600 units (120 microgram) if the duration of pregnancy is 20 weeks or less. If pregnancy is more advanced – 1500 units (300 micro grams) should be given.

 

Route of Administration  Deep I.M

 

Contraindications

It should never be given to the infant or to Rh-D positive persons since it will cause hemolytic of Rh positive RBCs.

 

Precaution / Practice points

The following criteria must be met before administration –

The mother should be Rh negative and not already sensitized and having anti ‘D’ antibodies in her plasma.

            The baby should be Rh positive.

·    100 mg (500 IY) neutralizes 4 –5 ml of Rh-positive blood. The usual recommended dose is 300 microgram. if more volume of feto-maternal haemorrhage is suspected, kleihauer’s test should be done  to find out amount of RBC entered into the maternal circulation and dose calculated accordingly.

·    It may interfere with immunologic response to other live vaccines like measles, mumps and rubella vaccines, which therefore should not be administered within 3 month of anti D immunoglobulin administration.

 

Adverse Effects

            Local reactions with pain and tenderness at the site of Im injection.

            Slight elevation of temperature.

 

Rare effects

·    Hypersensitivity – (fever, chills, facial flushing, headache, nausea).

 

Storage

            In a cool place.

            Do not allow to freeze, store at 2 – 8o C.

 

Shelf life         3 years.

 

TETANUS IMMUNOGLOBULIN

General Information

 

Drug code                   Preparation                                         Strength

      306                        Injection anti tentanus human                 250 IU

                                    immunoglobulin’

 

Description of the Drug

It is a preparation containing IgG immunoglobulin derived from plasma of donors sensitized to tentanus toxoid.

 

Mode of Action

The IgG antibodies acts to neutralize the free circulating exotoxisn of clostridium tetani and prevent
its fixation in tissue and its consequences.

 

Pharmacokinetics:

Peak levels are obtained 2 days after intramuscularly injection. Half-life of Ig G is 23 – 26 days.

 

Clinical Information

 

Indication

·    Prophylaxis against tentanus following injury.

·    Adjunct to active immunization with tetanus toxoid in an high-risk individual.

·    Part of regimen of treatment in active tentanus, to neutralize any circulating exotoxin.

 

Dosage

            Prophylaxis: 250 I.U. – I.M.  Both children and adult.

In active tentanus : 500 –10000 I.U. – I.M.(according to severity of infection ).

 

Route of Administration   Deep I.M.:

 

Contraindication

·    Hypersensitivity and anaphlactic reaction.

·    Not necessary if the individual has positively completed a primary series of vaccination against tetanus within the past 10 years.

 

Precaution/ Practice points:

·    Thrombocytopenia and coagulation disorders must be ruled out before I.M. administration.

·    Never administer I.V.

·    Proper wound debridement and active immunization must also be done, apart from I’m
administration for prophylaxis against tentanus.

 

Drug Interactions

It can interfere with response to other live vaccines like measles, mumps and rubella. Hence given a gap of 3 months before administering any live vaccine.

 

Adverse Effects

·    Pain and tenderness at the site of injection.

·    Hypersensitivity reactions, systemic reaction with fever, chills, facial flushing, headache, and nausea can occur.

 

Storage

            Do not allow to freeze, store at 2 – 8oC.

 

Shelf life         2 years.

 

SNAKE VENOM ANTISERUM

General Information

Drug code                   Preparation                                         Strength

      325                        Snake venom antiserum                        30 ml vial

 

Description of the Drug

·    It is a preparation containing specific immunoglobulins against toxinus in snake venum. The globulins are obtained by fractionation of serum of horses that have been immunized against the venoms of different stages.

·    10 ml of the preopation contains.

-  0.6 mg of dried cobra (Naja naja)

-  0.45 mg of common krait (bungarus caerulus).

-  0.6 mg of dried russels viper.

-  0.45 mg dried saw scale viper (echis carinatus).

Mode of Action

It neutralizes the toxic effects of the snake venom like myotoxic, neurotoxin and hemolytic effects.

It coagulates the proteins in the complex mixture of venom and destroys its enzymatic activity.

 

Pharmacokinetics:

Intravenous injection, intravenous infusion drips neutralizes the circulating toxins of the snake venom.

 

Clinical Information

 

Indications

Management of bites of venomous snakes like cobra common krait, Russels viper etc.

 

Dosage :

Minimal evenomation :

            (Local changes only, no systemic manifestation – 20 – 40 ml.

 

Moderate envenomation:

            (Local swelling with one or few systemic manifestations) – 50  -90 ml.

 

Severe envenomation:

            (Severe systemic manifestation)  - 100 – 150 ml.

Need for further dose depenss on clinical response.

 

Routes of Administration     IV bolus or continuous infusion.

 

Contraindications

History of allergy or hypersensitivity reactions.

 

Precaution / Practice points

·    Antivenin is generally given cautiously by IV infusion after suitable dilution over a period of 1 –2 hours slowly. The I.V. fluid to be used for dilution is 5 % dextrose only.

·    Resuscitation facilities should be available to combat anaphylxis.

·    Ideally skin test for hypersensitivity should be done for all patients by injecting 0.02 ml of a solution of 1 :10 dilution.

·    If hypersensitive – a wheal and flare reaction is obtained in 5 – 30 minutes.

·    If doubtful reading diphenhydramine can be given  IV prior to administration of snake venom antiserum.

 

Adverse Effects

            The most important complications development of anaphylaxis.

Symptoms are :

·    Flushing, itching urticaria, facial edema, cough, breathlessness, collapse.

·    Serum sickness may develop 5 – 24 days after administration symptoms are malaise, fever, urticaria, lymphadenopathy arthralgia or neurologic manifestation.

·    Treatment  of anaphylaxis – airway clearance , epinephrine, steroids, other antishistaminics, with monitoring of vital signs.

 

Storage

Store at temperature between 2-5o C protected from sunlight.

 

Shelf life         3 months.

           

 

 

CYCLOSPORIN

 

General Information

 

Drug code                   Preparation                                         Strength

      326                        Liq. Cyclosporin                                   50 ml  

                                    Oral preparation.

 

Description of the Drug

It is a cyclic polypeptide with  11 aminoacides, obtained from a fungus, beauveria nivea.

 

Mode of Action

Its effects are duet to specific inhibition of T lymphocytes in GO and GI phase of cell cycles. It also inhibits production and release of lymphokines like IL – 2.

 

Pharmacokinetics:

It is incompletely absorbed from GIT. The biavailiaility is about 30 %. Pack blood concentration achieved in about 3. Hours, after a n oral dose. It is metabolized in liver an almost entirely excreted in the bile. It crosses the placental barrier and is secreted into breast milk.

 

Clinical information


Indications

·    Kidney, liver, heart transplants – for prophylaxis of organ rejection. Can be used in conjunction with azathioprine an corticosteriods.

·    Rheumatoid  arthritis can be used in combination with methotrexate in patients who don’t respond to methotrexalone.

·    Psoriasis patients with extensive plaque lesions, who other therapies have failed.

·    Can also be used in treatment of chronic rejection patients previously treated with other
immunosuppressive.

 

Dosage

In organ transplantation – initial dose is 10 –15 mg/starting 4 – 12 hours before transplantation and continued 1 –2 weeks after the procedure. This is followed by maintenance therapy.

            Maintenance dose – 5  -10 mg/kg/day.

 

Route of Administration   oral

 

Contraindications

·    Patients with compromised renal function.

·    Uncontrolled hypertension.

·    Malignancies.

·    Psoriasis patients who have been treated with PUVA or therapy (risk of skin malignancy).

·    Pregnancy and lactation.

·    In AIDS patients, use of cyclosporin may have deleterious effects.

 

Precaution / Practice points

The drug increases susceptibility to infections and plasmas (lymphomas).

·    Blood pressure and renal function tests should be done prior to therapy.

·    Serum creatinine, electrolytes, blood pressure liver function tests and serum cholesterol to be
measured every 2 weeks for the first 3 month of therapy.

·    If co-administered with other drugs like methotrexate blood counts also to be monitored regularly.

·    If signs of cyclosporin induced nephropathy occur (increasing serum creatinine)graft  rejection in kidney transplant patients has to  be ruled out and dosage of cyclosporin reduced.

·    If hypertension occurs, treat with dosage reduction and anthihyperatives (except potassium sparing diuretics).

·    Live vaccines should not be administered to patients on cyclospporin.

·    Administration Instructions:

-  Take at the same time each day.

-  Take with food.

 

Drug Interactions

Potentially fatal:

·    Other drugs which are nephrotoxic should not be given to patients on cyclosporin.

-  Aminoglycosides : gentamycin, tobramycin.

-  Vancomycin , cotraimoxazole.

-  Diclofenac, naproxen, sulindac.

-  Amphotericin B, ketoocoazole.

-  Melphalan.

·    Drugs inhibiting cytochrome p450 increase cyclosporin concentration (and hence toxicity such as .

-  diltiazem, verapamil.

-  Fluconazole, intraconazole, ketoconazole.

-  Erythromycin, clarithromycin.

-  Steroids like methyl prednisolone.

-  Metaclopramide , allopurinol, danazol, bromocrptine.

·    Cyclosporin increases methotrexate, digoxin, prednisolone concentrations if administered together.

Non fatal

Drugs decreasing cyclosporin concentrations are

rifampicin , nafcilin.

-  Carbamazipine , phenobarbitol, phenytoin.

-  Ticlopidine.

Potassium sparing diuretics should not be given to patients with cyclosporin because hyperkalemia can occur.

 

Adverse Effects

Common effects:

·    Renal dysfunction: interstitial fibrosis can occur. This is dose related, leading to decreased renal function and elevation of blood urea nitrogen and serum creatinine.

·    Hypertension: mild to moderate hypertension is common. Antiypertensives to control the condition is required but potassium sparing diuretics should not to be given.

·    Hirusuitism, acne, tremor and gum hyperplasia.

·    Nausea, vomiting, diarrhoea.

Rare effects

·    Electrolytes disturbances like hyperkalemia, hyperuricemia hypomagnesemia.

·    Hepatotoxicity – usually within the first month of therapy – manifested as increased bilirubin and liver enzymes it may respond to a decrease in the dose.

·    Seizures, headache.

·    Thrombocytopenia and microangiopathic haemolytic anaemia.

·    Increased risk of malignancies – non-Hodgkin lymptoma and skin malignancies.

·    Anaphylactic reaction – facial flushing, B.P. changes dyspnoea, bronchospam, may occur.

·    Myositis, myalagia, paraestheisas.

·    Increased susceptibility to infections.

 

Drug Toxicity

            Hepatoxicity and nephrotoxicity (acute tubular necrosis may occur).

           

Treatment of Toxicity

·    Forced emesis if ingestion is within 2 hours.

·    Symptomatic treatment.

 

Storage

            Store in airtight containers, protected from light.

 

Shelf  life        2 years.

 

 

 

RABIES VACCINE

 

General Information

 

Drug code                   Preparation                                         Strength

       444                       Anti rabies vaccine                                30 ml vial

                                    Oral preparation.

 

Description of the Drug

It is a 5 % suspension of neural tissue vaccine prepared from sheep brain inactivated by beta propiolactone.

 

Mode of Action

It triggers off active immunity against the rabies virus by acting as an antigen, against which antibodies are produced. Though it is antigenic, it is rendered nontoxic by preserving with beta propiolactone.

 

Pharmacokinetics :

Injected subcutanesously , from where it acts as an antigen to provoke active immunity.

 

Clinical Information

 Indication

Primary pre exposure prophylaxis in high-risk individuals. 2-5 ml subcutaneously, in the anterior abdominal wall, for 7 to 14 days.

 

Dosage:

            Post exposure prophylaxis 2 –5 ml for 7 – 14 days.

 

Route of Administrations      S.C

 

Contraindications

            Hypersensitivity.

 

Drug Interactions

Immunosuppressive agents mute not be administered as it might interfere with developments.

 

Adverse Effects

Vaccine associated encephalitis is a risk associated with neural tissue vaccine, occurs due to cross-reaction with antibodies to human neural tissue.

 

Storage

            Store at 2 – 8oC.

 

Shelf life         2 years.

 

TETANUS TOXOID

General Information

 

Drug code                   Preparation                                         Strength

      999                        Tetanus Toxoid                                     0.5 mlvial

 

Description of the Drug

It is a preparation of toxoid absorbed on aluminum phosphate, which, after processing, is rendered antigenic but nontoxic.

 

Mode of Action

·    The toxoid triggers off active immunity of the host and production of antibodies to the tetanus toxins. Hence the person is rendered immune to the disease and exposure to the organisms of its toxin does not produce the disease.

·    A completed primary series of immunization affords protection for  10 years.

 

Pharacokinetics:

The toxiod is administered intramuscularly and is slowly absorbed from its site, sensitizing the host and stimulating the formation of antibodies against the toxins of tetanus bacilli.

 

Clinical information

 

Indications

·    Part of the immunization schedule for all children  (combined with DPT).

·    Pregnancy – in the II trimester, with a booster, 4 weeks prior to date of delivery.

·    Prophylactically in wounded and injured individuals.

 

Dosage

·    Primary course of immunization (in previously unimmunised) – 2 doses with 4 week interval, of 0.5 ml each , followed by a 3 rd dose of 0.5 ml , 6 months later.

·    Immunization in an infant (combined with DPT) at 6,10,14 weeks with a booster (of D.T) 6 months later.

·    Wounded persons with primary course completed within past 10 years – one booster dose.

·    Wounded persons with unknown immunization status – complete course of vaccination, combined with passive immunization.

 

Route of Administration  Deep  I.M.

 

Contraindications

·    Hypersensitivity to tetanus toxiod or to any of its products or components.

·    Occurence of any neurological complications on prior occasions of exposure to the vaccine.

 

Precaution / Practice points

·    Defer immunization during any outbreak of poliomyelitis, since injection is an important cause of provocative poliomyelitis.

·    Equipment for treating any anaphylaxis that might occur must be available.

 

Drug Interactions

Non fatal

·    Administration to patients who are on immunosuppressants including steroids or radiotherapy, results in insufficient immunization.

·    Concurrent administration with chloramphenicol may impair  amnesic response to TT.

·    Concurrent uses with tentanus immunoglobulin may delay development of active immunity by several days.

 

 

Adverse Effects

Local:

·    Erythema, indurations surrounding the injection site, pruritis , pain and tenderness.

·    Nodule or steierile abscess formation may occur.

Systematic manifestations:

·    Fever, chills and myaligia, may occur in patients who have been over sensitized with repeated doses.

·    Very rarely, neurologic complications such as encephalopthy, convulsions, and guillain bare syndrome have been reported.

 

Storage

            Do not freeze, store at 2 –8oC .

 

Shelf life         2 years.