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16 Cards in this Set

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PREGNANCY CATEGORY A
- Controlled studies show no risk to the fetus.

- Adequate well-controlled studies in pregnant women have not demonstrated risk to the fetus
2
PREGNANCY CATEGORY B
- There is no evidence of risk in humans.

- Animal studies show risk, but human findings do not.
- If no adequate human studies have been done, animal studies are negative.
3
PREGNANCY CATEGORY C
- Risk cannot be ruled out.

- Human studies are lacking, and animal studies are either positive for fetal risk or lacking.

- The drug may be used during pregnancy if the potential benefits of the drug outweigh its possible risks.
3
PREGNANCY CATEGORY D
- There is positive evidence of risk to the human fetus.

- Investigational or postmarketing data show risk to the fetus.

- However, potential benefits may outweigh the risk to the fetus. If
needed in a life-threatening situation or a serious disease, the drug may be acceptable if safer drugs cannot be used or are ineffective.
3
PREGNANCY CATEGORY X
- Use of the drug is contraindicated in pregnancy.

- Studies in animals or humans or investigational or postmarketing reports, have shown fetal risk that clearly outweighs any possible benefit to the patient.
2
Pharmacokinetics
- Refers to activities within the body after a drug is administered

- These activities include
absorption, distribution, metabolism, and excretion
(ADME).
Half-life
- Refers to the time required for the body to eliminate 50% of the drug

- Knowledge of the half-life of a drug is important in planning the frequency of dosing.
Pharmacodynamics
deals with the drug’s action and effect within the body.
Drug idiosyncrasy
is a term used to describe any unusual or abnormal reaction to a drug
Drug tolerance
is a term used to describe a decreased response to a drug, requiring an increase in dosage to achieve the desired effect.
Parenteral drug administration means
the giving of a drug by the subcutaneous (SC), intramuscular (IM),
intravenous (IV), or intradermal route
ILOMEDIN(Iloproset)
indications:
-severe peripheral arterial occlusive disease (PAOD), particularly those at risk of amputation and in whom surgery or angioplasty is not possible

-advanced thromboangiitis obliterans (Buerger's disease) with critical limb ischaemia in cases where revascularisation is not indicated

-patients with severe disabling Raynaud's phenomenon unresponsive to other therapies

-moderate or severe primary and secondary pulmonary hypertension such as New York Heart Association functional classes III and IV
Ilomedin(Iloproset) side effects:
1.Metabolism/nutrition disorders:
-anorexia

2.Nervous system disorders/ psychiatric disorders :
-dizziness, vertigo, giddiness, par-esthesia, hyper-esthesia, burning sensation, tingling, throbbing sensation, restlessness, agitation, sedation, apathy, drowsiness

3.Cardiac and vascular disorders !:
-headache, flush
(very common!!!)
-hypotensive reaction, bradycardia
(common!!!)

4.Gastrointestinal disorders:
-nausea, vomiting
(very common)

-diarrhoea, abdominal complaints, pain

5.Skin disorders:
-sweating
(very common!!!)
3 major systems
Ilomedin(Iloproset)
mechanism of action:
Iloprost is a prostacyclin analogue. The following pharmacological effects have been observed:

-Inhibition of aggregation, platelet adhesion and release reaction

-dilatation of arterioles and venules, increase of capillary density and reduction of increased vascular permeability in the microcirculation

-activation of fibrinolysis, inhibition of adhesion and immigration of leucocytes after an endothelial lesion, and reduced release of oxygen free radicals
Ilomedin(Iloproset)
administration
I.V

In general, the ready-to-use infusion solution is infused intravenously by means of an infusion pump .
For this purpose, the contents of an ampoule of 0.5 ml ILOMEDIN are diluted with 250 ml of a sterile physiological saline solution or a 5 % glucose solution. The contents of the ampoule and the diluent should be mixed thoroughly. In the case of an ILOMEDIN concentration of 0.2 µg/ml, the required infusion rate should be determined according to the above descibed scheme to effect a dose within the range of 0.5 to 2.0 ng/kg/min.
Ilomedin(Iloproset)
interactions
-Beta bl.
-calcium antagonists and vasodilators
-ACE inh.

(additive effect on the antihypertensive activity and as the result orthostatic hypotension!)