Ibugesic may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Ibugesic in the following countries:
International Drug Name Search
Each light blue film coated tablet contains:
| Vitamin C (Ascorbic Acid) | 100 mg |
| Vitamin D-3 (Cholecalciferol) | 400 IU |
| Vitamin E (dl-Alpha Tocopheryl Acetate) | 30 IU |
| Vitamin B-1 (Thiamine HCl) | 1.6 mg |
| Vitamin B-2 (Riboflavin) | 1.6 mg |
| Niacin (Niacinamide) | 20 mg |
| Vitamin B-6 (Pyridoxine HCl) | 3.1 mg |
| Folic Acid | 1 mg |
| Vitamin B-12 (Cyanocobalamin) | 12 mcg |
| Calcium (Calcium Carbonate) | 200 mg |
| Iron (Ferrous Fumarate) | 27 mg |
| Zinc (Zinc Oxide) | 10 mg |
| Copper (Cupric Sulfate) | 2 mg |
TriCare® Prenatal tablets are indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center right away.
Folic acid alone is improper therapy in the treatment of prenicious anemia and other megaloblastic anemias where vitamin B-12 is deficient.
Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
One tablet daily or as directed by a physician.
TriCare® Prenatal Multivitamin/Mineral Tablets for oral administration are supplied as light blue, film coated tablets, debossed MP 101 with a partial bisect through the tablets on one side. In a child resistant plastic bottle of 100 tablets (NDC 67112-101-00).
acacia, croscarmellose sodium, dicalcium phosphate, FD&C blue #1 Lake, FD&C blue #2 Lake, FD&C red #40 Lake, gelatin, hypromellose, magnesium silicate, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyvinylpyrrolidone, silica, sodium lauryl sulfate, soy polysaccharide, stearic acid, titanium dioxide, and triacetin.
Store at controlled room temperature, 15o-30oC (59o-86oF)
NOTICE: Contact with moisture may produce surface discoloration or erosion of the tablet.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Marketed by Medecor Pharma LLC, Baton Rouge, LA 70802
| Tricare Prenatal ascorbic acid, cholecalciferol, dl-.alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric sulfate tablet, coated | |||||||||||||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 11/11/2002 | ||
| Labeler - Medecor Pharma, LLC (830621046) |
| Registrant - Medecor Pharma, LLC (830621046) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Catalent Australia PTY LTD | 753617638 | manufacture | |
REVAXIS
Suspension for injection in pre-filled syringe
Diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)
Each dose (0.5 ml) contains:
Active ingredients:
Purified diphtheria toxoid ............ not less than 2 IU* (5 Lf)
Purified tetanus toxoid ............ not less than 20 IU* (10 Lf)
Inactivated poliomyelitis virus type 1**....................... 40 D antigen units***
Inactivated poliomyelitis virus type 2**………………..……………... 8 D antigen units***
Inactivated poliomyelitis virus type 3**…………………………….…32 D antigen units***
aluminium hydroxide as adsorbant…………………………………… 0.35 mg (as aluminium)
For a full list of excipients, see section 6.1
* As lower confidence limit (p = 0.95) of activity measured according to the assay described in the European Pharmacopoeia.
** Produced in Vero cells.
*** Or equivalent antigenic quantity determined by a suitable immunochemical method
Suspension for injection in pre-filled syringe.
The vaccine has a cloudy white appearance.
REVAXIS is indicated for active immunisation against diphtheria, tetanus and poliomyelitis in children from six years of age, adolescents and adults as a booster following primary vaccination.
REVAXIS is not intended for primary immunisation.
Posology
The dose for children from the age of six years, adolescents and adults is 0.5 ml.
REVAXIS should be administered in accordance with official recommendations and/or local practice regarding the use of vaccines that provide reduced dose diphtheria toxoid plus tetanus toxoid in combination with inactivated poliomyelitis viruses.
REVAXIS may be used as a booster following primary immunisation with inactivated or oral poliomyelitis vaccines (IPV or OPV). There are no clinical data available regarding the use of REVAXIS in individuals with an incomplete, or no, history of a primary series of diphtheria and tetanus toxoids or of vaccinations against poliomyelitis.
Although REVAXIS has not been studied in subjects with tetanus-prone injuries, studies have shown that it induces similar tetanus antitoxin titres to Td vaccine. REVAXIS may therefore be used in subjects with tetanus-prone injuries if concomitant vaccination against diphtheria and poliomyelitis is desirable.
Method of Administration
REVAXIS is for intramuscular injection only. The recommended injection site is the deltoid region.
REVAXIS must not be administered by intradermal or intravascular routes.
Under certain conditions (e.g. bleeding disorders) REVAXIS may be administered as a deep subcutaneous injection.
For further instructions for use see section 6.6.
Hypersensitivity to diphtheria, tetanus or poliomyelitis vaccines or to any other ingredient of the vaccine.
Hypersensitivity to neomycin, streptomycin or polymyxin B. These are used during production and traces may remain in the vaccine.
Acute severe febrile illness. The presence of a minor infection is not a contraindication.
Neurological complications following an earlier immunisation against diphtheria and/or tetanus.
As for all vaccines, appropriate medical treatment should be readily available for immediate use in case of an anaphylactic reaction following vaccination.
REVAXIS should under no circumstances be administered intravascularly. The intradermal route must not be used either.
The immunogenicity of the vaccine could be reduced in immunosuppressed subjects. Where possible, vaccination should be postponed until immune function has recovered. However, vaccination of subjects with chronic immunodeficiency, such as AIDS, is recommended even if the antibody response might be limited.
REVAXIS must be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to such subjects.
In order to minimise the risk of adverse events, REVAXIS should not be administered to subjects who completed a primary vaccination course or received a booster of a vaccine containing diphtheria or tetanus toxoids within the previous five years.
If Guillain-Barré syndrome or brachial neuritis has occurred following receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.
REVAXIS may be administered at the same time as other vaccines or immunoglobulins provided that the injections are made at separate site.
Subjects who are taking immunosuppressive agents may not respond to REVAXIS (see section 4.4).
The effect of REVAXIS on embryo-foetal development has not been assessed in animals. No teratogenic effect of vaccines containing diphtheria or tetanus toxoids, or inactivated poliovirus has been observed following use in pregnant women. However, this vaccine should not be administered to pregnant women unless it is considered urgent to boost immunity.
REVAXIS may be administered to breastfeeding women.
Vertigo has been reported following vaccination.
The adverse events are ranked under headings of frequency using the following convention:
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Data from pre-approval clinical studies
In clinical studies, the most common events occurring after vaccine administration were local injection site reactions (pain, erythema, induration and oedema) reported by 65 to 80% of subjects in each trial. These usually had their onset within the 48 hours following vaccination and persisted for 1 to 2 days. These reactions are sometimes accompanied by injection site nodules.
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Data from post-marketing surveillance:
Based on spontaneous reporting, the following additional adverse events have been reported during the commercial use of REVAXIS.
These events have been very rarely reported, however exact incidence rates cannot precisely be calculated.
Nervous system disorders
Convulsions, Guillain Barre syndrome, brachial neuritis, transient paresthesia and hypoesthesia of the vaccinated limb, vasovagal syncope
Gastrointestinal disorders
Abdominal pain, diarrhoea
Skin and subcutaneous tissue disorders
allergic-type reactions such as urticaria, various types of rash, and face oedema
Musculoskeletal and connective tissue disorders
Pain in vaccinated limb
General disorders and administration site conditions
Large injection site reaction (>50 mm), including extensive limb swelling from the injection site beyond one or both joints have been reported. These reactions start within 24-72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within 3-5 days.
Pallor, asthenia, usually occurring and resolving within a few days, chills, influenza-like symptoms, mostly the same day as the vaccination
Immune system disorder:
systemic allergic / anaphylactic reactions including shock
Not documented.
Pharmacotherapeutic group: Vaccine against diphtheria, tetanus and poliomyelitis
ATC code: J07CA01
During clinical studies, the immunogenicity of REVAXIS was evaluated in 661 healthy subjects aged six to 78 years. In subjects vaccinated within ten years of a previous dose of diphtheria/tetanus/poliomyelitis vaccine, more than 99% achieved protective antibody levels for diphtheria, tetanus and poliomyelitis (types 1, 2 and 3) one month after receiving REVAXIS .
In a clinical study carried out in 113 healthy subjects aged 40 to 78 years who received their last vaccination against diphtheria, tetanus and poliomyelitis more than ten years ago, REVAXIS elicited a satisfactory booster response.
Antibody persistence over a two-year period was assessed in 113 healthy adults. Two years after receiving a dose of REVAXIS the proportions of subjects with protective titres against diphtheria, tetanus and poliomyelitis (types 1, 2 and 3) were 100%, 94.7% and 100% respectively. In a clinical study in 151 healthy children aged six to nine years, antibody titres at one month after a dose of REVAXIS were approximately three-fold higher than those seen in the healthy adults at two years post-dose. Therefore, it may be anticipated that antibody levels in children would be at least as good as those observed in adults at two years post-dose.
Evaluation of pharmacokinetic properties is not required for vaccines.
Preclinical data reveal no special hazard for humans based on conventional studies of safety, specific toxicity and compatibility of ingredients.
Phenoxyethanol
Formaldehyde
Medium 199*
Water for injections
* Medium 199 is a complex medium of amino acids, mineral salts, vitamins, polysorbate 80 and other substances diluted in water for injections.
In the absence of compatibility studies, the vaccine must not be mixed with other medicinal products.
3 years
Store in a refrigerator (2°C to 8°C).
Do not freeze. Discard the vaccine if it has been frozen.
0.5 ml of suspension in pre-filled syringe (0.5 ml, type I glass) with a plunger-stopper (chlorobromobutyl elastomer) and attached needle and needle-guard (natural rubber or polyisoprene elastomer).
0.5 ml of suspension in pre-filled syringe (0.5 ml, type I glass) with a plunger-stopper (chlorobromobutyl elastomer) and tip-cap (chlorobromobutyl elastomer), without needle.
Packs of 1, 10 and 20 syringes.
0.5 ml of suspension in pre-filled syringe (0.5 ml, type I glass) with a plunger-stopper (chlorobromobutyl elastomer) and tip-cap (chlorobromobutyl elastomer), with 1 or 2 separate needles (for each syringe).
Packs of 1 and 10 syringes.
Not all pack sizes and presentations may be marketed.
For needle free syringes, the needle should be pushed firmly on to the end of the pre-filled syringe and rotated through 90 degrees.
The vaccine's normal appearance is a cloudy white suspension that may sediment during storage. Shake the pre-filled syringe well to distribute uniformly the suspension before administering the vaccine.
Parenteral biological products should be inspected visually for extraneous particulate matter and/or discolouration prior to administration. In the event of either being observed, discard the vaccine.
Any unused product or waste material should be disposed of in accordance with local requirements.
Sanofi Pasteur MSD Limited
Mallards Reach
Bridge Avenue
Maidenhead
Berkshire
SL6 1QP
PL06745/0123
3rd June 2003/4th April 2008
April 2008
Class: Antineoplastic Agents
VA Class: AM800
Chemical Name: Interferon αA (human leukocyte protein moiety reduced)
Molecular Formula: C860H1353N227O255S9C860H1353N229O255S9C860H1353N227O255S9
CAS Number: 76543-88-9
Brands: Intron A, Infergen, Alferon N
Systemically administered interferon alfa may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders.b c Patients should be closely monitored with periodic clinical and laboratory evaluations.b c Discontinue therapy in patients with persistently severe or worsening signs or symptoms of these conditions.b c In many, but not all cases, these disorders resolve after the drug is discontinued.b c
REMS:
FDA approved a REMS for interferon alfa to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().
Interferon alfa is a family of homologous, species-specific proteins and, occasionally, glycoproteins with antiviral, antineoplastic, and immunomodulating activities.8 47 52 70 255 259 261 450 456 648 714 717 740 906 1211 1240 1241 1339 1426 1464
Available as interferon alfa-2b (Intron A; single interferon subtype, recombinant preparation); interferon alfacon-1 (Infergen; genetically modified interferon protein); and interferon alfa-n3 (Alferon N; a mixture of naturally occurring human interferon alfa proteins).
Interferon alfa-2b: Treatment of chronic HBV infection in adults and children ≥1 year of age with compensated liver disease.a
May be effective in HBeAg-positive patients who have elevated ALT values and in HBeAg-negative patients.a
Treatment of chronic HBV infection is complex and rapidly evolving; a specialist should be consulted to obtain the most up-to-date information regarding patient selection criteria and preferred regimens.a
Interferon alfa-2b, interferon alfacon-1: Treatment of chronic HCV infection in patients with compensated liver disease.b
Interferon alfa-2b is used alone or in conjunction with oral ribavirin.b
Interferon alfa-2b in conjunction with oral ribavirin is used for the treatment of HCV infection in treatment-naive children 3–17 years of age with compensated liver disease.b
Use of interferon alfa and oral ribavirin results in higher sustained response rates than use of interferon alfa alone.
Peginterferon alfa in conjunction with oral ribavirin is considered the treatment of choice for treatment-naive patients (have not previously received interferon alfa therapy) and for previously treated patients who fail to achieve a sustained virologic response following treatment with interferon alfa alone or in conjunction with oral ribavirin.
Interferon monotherapy generally is reserved for patients in whom ribavirin is contraindicated or not tolerated.
Data are limited in HIV-infected individuals.
Treatment of chronic HCV infection is complex and rapidly evolving; a specialist should be consulted to obtain the most up-to-date information regarding patient selection criteria and preferred regimens.
Interferon alfa-2b: Has been used for the treatment of acute HCV infection† in an attempt to prevent progression to chronic HCV infection. Sustained virologic response achieved in many patients given interferon alfa monotherapy.
Optimum regimen (including dosage and duration of therapy) not established. Therapy usually initiated 2–4 months after onset of acute hepatitis.
Interferon alfa, with or without oral ribavirin, is not recommended for postexposure prophylaxis of HCV† following occupational exposure to HCV.
Interferon alfa: Has been used with some limited success in the management of chronic hepatitis D virus infection† in adults and children coinfected with HBV.
Interferon alfa-2b: Treatment of external genital and perianal exophytic warts (condylomata acuminata) caused by HPV.
Interferon alfa-n3: Treatment of refractory or recurring external warts (condylomata acuminata) caused by HPV.d
Interferon alfa not considered a first-line agent for the treatment of external HPV warts because of the inconvenient route of administration, need for frequent clinician visits, and high frequency of systemic adverse effects.g CDC recommends that external HPV warts be treated with a self-administered topical therapy (podofilox, imiquimod), a topical therapy administered by a health-care provider (podophyllum resin, trichloroacetic acid [TCA], bichloroacetic acid [BCA]), or a surgical technique (cryotherapy, electrosurgery, surgical excision).g Intralesional interferon alfa or laser surgery are alternatives.g
Primary goal is destruction or clearance of visible warts.g No regimen has been shown to eradicate HPV infection; effect on transmission of HPV unknown.g
Interferon alfa-2b: Under investigation for the treatment of symptomatic West Nile virus infection†.
Low-dose oral interferon alfa was investigated in patients with HIV infection†; low-dose oral interferon alfa is not effective for the treatment of HIV infection.
Interferon alfa-2b: Treatment of hairy cell leukemia2 4 135 153 219 1620 1621 1623 1627 1629 1635 (leukemic reticuloendotheliosis).171 1636
Complete response achieved in 10% of patients and overall response achieved in approximately 80% of patients.2 4 119 121 122 123 124 125 126 127 128 129 130 131 132 134 135 136 138 141 142 143 170 175 178 181 182 184 185 188 193 194 195 199 200 202 219 220 248 249 250 252 253 260 1620 1624 1630 1635 1636 h
Used as an alternative agent for hairy cell leukemia; cladribine or pentostatin are first-line agents (achieve higher complete response rates than interferon alfa).1619 1620 1621 1622 1623 1624 1625 1627 1630 1632 1637 h
Interferon alfa-2b: Palliative treatment of AIDS-related (epidemic) Kaposi’s sarcoma in selected adults2 152 153 204 206 210 377 378 1647 1648 1649 (designated an orphan drug by FDA for this indication).1546
Should not be used in patients with rapidly progressive or life-threatening disease;2 153 1549 1692 response generally is slow91 156 1549 1692 and poor.2 145 153 154 155 156 196 203 204 378 381 383 384 385 386 387 388 389 1549
Interferon alfa-2b: Has been used for the treatment of adult-type (Philadelphia chromosome-positive) chronic myelogenous (myelocytic, myeloid) leukemia (CML)†259 260 261 299 300 301 302 303 305 306 307 308 309 310 311 312 1029 1420 1479 1533 1594 1638 1639 1640 1641 1642 1643 1644 1645 (designated an orphan drug by FDA for this indication).1546
Interferon alfa-2b: Although labeled for use in conjunction with an anthracycline for the initial treatment of clinically aggressive follicular non-Hodgkin's lymphoma in adultsb , other agents are preferred.i
Efficacy in patients with low-grade, low-tumor-burden follicular non-Hodgkin's lymphoma not demonstrated.b
Interferon alfa: Has been used for the treatment of cutaneous T-cell lymphomas†.88 92 172 254 257 299 302 342 348 1109 1110 1111 1117 1118 1382 1385
Interferon alfa: Has been used in the treatment of metastatic renal cell carcinoma† in selected patients.715 1625 1693 1694 1697
Interferon alfa: Has been used for prophylaxis351 or treatment356 1065 1552 of superficial bladder cancer†.
May be useful as second-line agent.351
Interferon alfa: Has been used intraperitoneally for the treatment of minimal residual epithelial ovarian cancer† in a limited number of patients.358 359 360
Interferon alfa: Has been used intralesionally for the treatment of basal cell carcinoma†272 1466 1467 1468 1469 1470 and squamous cell carcinoma†.158
Interferon alfa-2b: Used as an adjunct to surgery1609 (within 56 days of surgery) in adults with melanoma who are disease free but at high risk for systemic recurrence.b e
Palliative treatment of metastatic melanoma† in selected patients, alone and in combination with other agents.1342 1343 1344 1345 1346 1347 1443 1444 1445 1446 1530 1531 1532 1646
Available in several interferon alfa subtypes and dosage forms (powder for injection, solution for injection, multiple-dose pens);b c d preparation to be used and appropriate concentration depend on the intended use.b Ensure that the correct preparation is used.b c d
Interferon alfa-2b (Intron A): Administer by IM, sub-Q, or intralesional injection or IV infusion.b
Interferon alfacon-1 (Infergen): Administer by sub-Q injection.c
Interferon alfa-n3 (Alferon N) : Administer by intralesional injection.d
Interferon alfa-2b (Intron A) and alfacon-1 (Infergen) may be self-administered if the clinician determines that the patient and/or their caregiver are competent to prepare and safely administer the drug after appropriate training and with medical follow-up as necessary.2
When feasible, administer in the evening or at bedtime to prevent or ameliorate adverse effects. Consider concomitant use of acetaminophen to reduce adverse effects.
Reconstitute vial of interferon alfa-2b powder for injection containing 10, 18, or 50 million units of the drug by adding 1 mL of sterile water for injection.b Swirl gently.b Withdraw appropriate dose and add to 100 mL of 0.9% sodium chloride injection.b Do not dilute to a final concentration <100,000 units/mL.b Prepare solutions immediately before use.b
Interferon alfa-2b powder for injection containing 10, 18, or 50 million units intended for use in the induction phase of treatment for malignant melanoma.b
Infuse over 20 minutes.b
Do not administer interferon alfa-2b solution for injection by IV injection.b
Reconstitute vial of interferon alfa-2b powder for injection containing 10, 18, or 50 million units of drug by adding 1 mL of sterile water for injection.b Swirl gently.b
Interferon alfa-2b solution for injection is administered undiluted.b
Administer interferon alfa-2b into anterolateral thigh, upper arm, or outer area of the buttocks.b
Vial size to be used and appropriate concentration depend on the intended use.b
Vials of interferon alfa-2b powder for injection containing 10 million units and the solution for injection containing 10 million units/mL are intended for use in the treatment of HBV infection.b
Vials of interferon alfa-2b powder for injection containing 18 million units are intended for use in the treatment of HCV infection.b
Vials of interferon alfa-2b powder for injection containing 10 million units and the solution for injection containing 6 or 10 million units/mL are intended for use in the treatment of hairy cell leukemia.b
Vials of interferon alfa-2b powder for injection containing 50 million units are intended for use in the treatment of AIDS-related Kaposi’s sarcoma.b
Interferon alfa-2b solution for injection in multiple-dose pens should not be used for IM injection.
Do not use vials of interferon alfa-2b powder for injection containing 50 million units to prepare solutions for treatment of HBV or HCV infection; volume of drug required would be small and subject to possible inaccurate measurement.f
Reconstitute vial of interferon alfa-2b powder for injection containing 10, 18, or 50 million units of drug by adding 1 mL of sterile water for injection.b Swirl gently.b
Interferon alfa-2b solution for injection is administered undiluted.b Available in vials. Also available in multiple-dose pens designed to deliver 3–12 doses of the drug. Use the needles provided with the pens; use a new needle for each dose.
Administer interferon alfa-2b into anterolateral thigh, upper arm, or abdomen (avoid the navel).b
Vial size to be used and appropriate concentration depend on the intended use.b
Vials of interferon alfa-2b powder for injection containing 10 million units, the solution for injection containing 10 million units/mL, and the multiple-dose pen containing 22.5, 37.5, or 75 million units are intended for use in the treatment of HBV infection.b
Vials of interferon alfa-2b powder for injection containing 18 million units and the multiple-dose pen containing 22.5 million units are intended for use in the treatment of HCV infection.b
Vials of interferon alfa-2b powder for injection containing 10 million units, the solution for injection containing 6 or 10 million units/mL, and the multiple-dose pens containing 22.5 or 37.5 million units are intended for use in the treatment of hairy cell leukemia.b
Vials of interferon alfa-2b powder for injection containing 50 million units are intended for use in the treatment of AIDS-related Kaposi’s sarcoma.b
Vials of interferon alfa-2b powder for injection containing 10 million units, the solution for injection containing 6 or 10 million units/mL, and the multiple-dose pens containing 37.5 or 75 million units are intended for use in the treatment of follicular lymphoma.b
Vials of interferon alfa-2b powder for injection containing 10 or 18 million units, the solution for injection containing 6 or 10 million units/mL, and the multiple-dose pens containing 22.5, 37.5, or 75 million units are intended for the maintenance phase in the treatment of malignant melanoma.b
Interferon alfacon-1 is administered undiluted.c
Vials are for single-use only; any unused portion should be discarded.c
Administer into anterolateral thigh, upper arm, or abdomen (avoid the navel and waist).c
Reconstitute vial of interferon alfa-2b powder for injection containing 10 million units of drug by adding 1 mL of sterile water for injection.b Swirl gently.b
Interferon alfa-2b solution for injection containing 10 million units/mL is administered undiluted.b
Use a tuberculin or similar syringe and a 25- to 30-gauge short (e.g., 0.25- to 0.5-inch) needle. Direct needle toward the center of the base of the wart, at an angle nearly parallel to the plane of the skin to deliver the drug to the core of the lesion.
Vials of the powder for injection containing 18 or 50 million units should not be used to prepare solutions for intralesional injection; solution would be hypertonic.f Multiple-dose pens should not be used for intralesional injection.
Interferon alfa-n3 is administered undiluted.d
Use a 30-gauge needle.d Direct needle toward the base of the wart.d
Because there are differences in the potencies and differences in recommended dosages and routes of administration among the various commercially available interferon alfa preparations, it is recommended that the interferon alfa preparation selected for the patient be used throughout the treatment regimen.
Children ≥1 year of age: 3 million units/m2 3 times weekly for the first week, then 6 million units/m2 3 times weekly (maximum of 10 million units 3 times weekly).b
Recommended duration of treatment is 16–24 weeks in HBeAg-positive patients and ≥12 months in HBeAg-negative patients.a
Dosage modification for toxicity: Reduce dosage by 50% in patients with leukocyte counts <1500/mm3, granulocyte counts <750/mm3, or platelet counts <50,000/mm3.b If leukocyte, granulocyte, and/or platelet counts return to normal or baseline values, resume at the initial dosage.b Permanently discontinue in those with leukocyte counts <1000/mm3, granulocyte counts <500/mm3, or platelet counts <25,000/mm3.b
Children ≥3 years of age: Interferon alfa-2b 3 million units 3 times weekly. Given in conjunction with oral ribavirin (200 mg twice daily for children weighing 25–36 kg, 200 mg every morning and 400 mg every evening for those weighing 37–49 kg, 400 mg twice daily for those weighing 50–61 kg). Children weighing >61 kg may receive the usual adult dosage of ribavirin.
Dosage modification for toxicity: If severe adverse effects develop, reduce dosage of interferon alfa-2b by 50% or temporarily interrupt therapy until adverse events resolve.b Discontinue if intolerance persists after dosage adjustment.b
30–35 million units per week given as 5 million units once daily or 10 million units 3 times weekly.
Recommended duration of treatment is 16–24 weeks in HBeAg-positive patients and ≥12 months in HBeAg-negative patients.a
Dosage modification for toxicity: Reduce dosage by 50% in patients with leukocyte counts <1500/mm3, granulocyte counts <750/mm3, or platelet counts <50,000/mm3.b If leukocyte, granulocyte, and/or platelet counts return to normal or baseline values, resume at the initial dosage.b Permanently discontinue in those with leukocyte counts <1000/mm3, granulocyte counts <500/mm3, or platelet counts <25,000/mm3.b
Interferon alfa-2b 3 million units 3 times weekly.b Given in conjunction with oral ribavirin (400 mg every morning and 600 mg every evening for those weighing ≤75 kg or 600 mg every morning and every evening for those weighing >75 kg).
Manufacturer recommends continuing the regimen for 18–24 months, depending on baseline disease characteristics, virologic response, and/or tolerability.b
Dosage modification for toxicity: If severe adverse effects develop, reduce dosage of interferon alfa-2b by 50% or temporarily interrupt therapy until adverse events resolve;b the recommended dosage of ribavirin is 200 mg every morning and 400 mg every evening. Discontinue if intolerance persists after dosage adjustment.b
3 million units 3 times weekly.b
Manufacturer recommends continuing the regimen for 18–24 months, depending on baseline disease characteristics, virologic response, and/or tolerability.b
Dosage modification for toxicity: If severe adverse effects develop, reduce dosage by 50% or temporarily interrupt therapy until adverse events resolve.b Discontinue if intolerance persists after dosage adjustment.b
9 mcg 3 times weekly.c Allow at least 48 hours to elapse between doses.c Manufacturer recommends continuing regimen for 24 weeks.c
Individuals who tolerated previous interferon therapy and did not respond to the initial regimen or relapsed after discontinuance may receive 15 mcg 3 times weekly for up to 48 weeks.c
Dosage modification for toxicity: Temporarily interrupt therapy for severe adverse reaction; discontinue if adverse reaction does not subside to a tolerable level.c Consider reducing dosage to 7.5 mcg 3 times weekly.c May need to reduce dosage to <7.5 mcg 3 times weekly; long-term administration of this dosage may compromise efficacy.c
1 million units into each lesion (up to 5 lesions) 3 times weekly on alternate days for 3 weeks.
Another course may be administered after 12–16 weeks.b
250,000 units (0.05 mL) into each wart twice weekly for up to 8 weeks. Maximum dose per treatment session is 2.5 million units.d
Large warts may be injected at multiple locations around their periphery, using a total dose of 250,000 units per lesion.
Dosage modification for toxicity: Regimen may need to be modified or discontinued in patients who experience moderate to severe adverse effects.
Delay administration of a second course or other therapy until 3 months after first course unless warts enlarge or new lesions develop; many patients do not exhibit complete resolution of lesions until 3 months following cessation of therapy.
The safety and efficacy of a second course not determined.
Loading dose of 3 million units by IV infusion over 20 minutes, 3 million units sub-Q 12 hours later, then 3 million units sub-Q every 24 hours for a total of 14 days has been used.
2 million units/m2 3 times weekly for up to 6 months.2 124 126 129 131 132 135 141 172 179 185 186 194 220 252 1152 1153 b
Discontinue if disease progresses or fails to respond after 6 months of therapy.b
Dosage modification for toxicity: If severe adverse effects develop, reduce dosage by 50% or temporarily interrupt therapy until adverse events resolve.b Resume with dosage of 1 million units/m2 3 times weekly.b Discontinue if severe adverse effects persist or recur after dosage adjustment.b
FDA-labeled dosage is 30 million units/m2 3 times weekly.2 Doses of 4–18 million units/m2 have been used in patients receiving antiretroviral therapy.j
Dosage modification for toxicity: If severe adverse effects develop in patients receiving FDA-labeled dosage, reduce dosage by 50% or temporarily interrupt therapy until adverse events resolve.b May resume at reduced dosage if adverse effects subside.b Discontinue if severe adverse effects persist or recur after dosage adjustment.b
5 million units 3 times weekly in conjunction with anthracycline-containing chemotherapy regimen; continue interferon alfa-2b after completion of the chemotherapy regimen.b Interferon alfa-2b is given for up to 18 months.b
Dosage modification of interferon alfa-2b for toxicity: Withhold for neutrophil counts <1000/mm3 or platelet counts <50,000/mm3.b Reduce by 50% for neutrophil counts of 1000–1500/mm3.b May reescalate to starting dosage after neutrophil counts increase to >1500/mm3.b Discontinue for AST >5 times the ULN or Scr >2 mg/dL.b
Doses of myelosuppressive drugs were reduced by 25% from full dose and cycle length increased by 33% (e.g., from 21 to 28 days) when interferon alfa was added to the regimen.b Delay cycle for neutrophil counts <1500/mm3 or platelet counts <75,000/mm3.b
Induction therapy: 20 million units/m2 daily for 5 consecutive days per week for 4 weeks.1609 1652
Dosage modification for toxicity: Withhold for serious adverse effects including granulocyte count 250–500/mm3 or ALT and/or AST >5 to 10 times the ULN.b When adverse reaction subsides, reinitiate at 50% of the previous dosage.b Discontinue if toxicity does not subside while the drug is withheld; if serious adverse effects recur after dosage adjustment; and for granulocyte count <250/mm3 or ALT/AST >10 times the ULN.b
Maintenance therapy: 10 million units/m2 3 times weekly for 48 weeks.1609 1652
Dosage modification for toxicity: Withhold for serious adverse effects including granulocyte count 250–500/mm3 or ALT and/or AST >5 to 10 times the ULN.b When adverse reaction subsides, reinitiate at 50% of the previous dosage.b Discontinue if toxicity does not subside while the drug is withheld; if serious adverse effects recur after dosage adjustment; and for granulocyte count <250/mm3 or ALT and/or AST >10 times the ULN.b
Maximum dosage is 10 million units 3 times weekly.b
Maximum number of lesions treated per course is 5.b
The maximum recommended dose per treatment session is 2.5 million units.
No special population dosage recommendations at this time.e f
Use of interferon alfa-2b or interferon alfacon-1 in patients with autoimmune hepatitis.b c
Use of interferon alfa-2b or interferon alfacon-1 in patients with hepatic decompensation.b c
Hypersensitivity to interferon alfa or any ingredient in the formulations.b c d
Concomitant interferon alfa-2b and ribavirin therapy: Ribavirin is contraindicated in pregnant women; men whose female partners are pregnant; patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia); patients with Clcr <50 mL/minute.b
Hypotension,2 148 206 208 257 260 261 266 376 431 470 arrhythmias,2 4 260 300 374 376 461 465 469 470 475 MI,2 4 11 102 259 261 266 341 376 450 461 465 470 471 473 474 490 963 sudden death,259 261 376 471 472 474 963 and cardiomyopathy2 155 204 469 470 1340 1362 reported in patients receiving systemically administered interferon alfa.
Perform baseline ECG before initiation of systemic therapy in patients with preexisting cardiac abnormalities.b Use with caution and with close monitoring in those with a history of MI and arrhythmic disorders.b
Ischemic and hemorrhagic cerebrovascular events, including hemorrhagic stroke, reported in patients receiving systemically administered interferon alfa.b c TIAs have occurred in young patients.c
Potentially fatal neuropsychiatric events (suicide, suicidal ideation, depression, aggressive behavior) reported in patients receiving systemically administered interferon alfa.b c
Monitor patients who develop psychiatric symptoms, including depression.b c Discontinue and provide appropriate psychiatric intervention if severe depression and/or other psychiatric condition occurs.
Use of systemically administered interferon alfa is not recommended in patients with a history of psychiatric disorders.b c
Encephalopathy reported in patients (usually geriatric patients) receiving high doses of interferon alfa-2b.b
Severe cytopenias may occur in patients receiving systemically administered interferon alfa; aplastic anemia reported rarely.b c
Perform CBCs prior to and routinely during therapy.b c Adjust dosage or discontinue drug if necessary.b c
Decrease or loss of vision, retinal artery or vein thrombosis, retinal hemorrhages and cotton-wool spots reported in patients receiving systemic interferon alfa; in addition, these agents may induce or aggravate optic neuritis and papilledema.b c
Perform baseline ophthalmologic examinations prior to initiation of therapy in all patients; evaluate patients with preexisting ophthalmologic disorders (e.g. diabetic or hypertensive retinopathy) periodically during therapy.b c Any patient who develops ocular symptoms should receive a prompt and complete eye examination.b c
Discontinue therapy in patients who develop new or worsening ophthalmologic disorders.b c
Thyroid dysfunction (hypothyroidism2 376 507 508 510 1361 1533 1565 or hyperthyroidism)2 376 507 509 510 1361 1362 1533 1565 1609 has occurred in patients receiving systemically administered interferon alfa. Evaluate TSH concentrations prior to initiation of interferon alfa. Any patient who develops symptoms of thyroid dysfunction should have their thyroid function evaluated and treatment initiated if needed.b
Patients with hypothyroidism or hyperthyroidism whose disease cannot be effectively treated should not receive interferon alfa.
Diabetes mellitus reported in patients receiving systemically administered interferon alfa.b c Patients with diabetes mellitus whose disease cannot be effectively treated should not receive interferon alfa.b
Hepatotoxicity, sometimes fatal, reported in patients receiving systemically administered interferon alfa. Closely monitor patients who develop liver function abnormalities; discontinue therapy if needed.b
Patients with chronic HBV or HCV infection and decompensated liver disease, autoimmune hepatitis, or a history of autoimmune disease, and transplant recipients receiving immunosuppressive therapy may be at risk of worsening liver disease, jaundice, hepatic encephalopathy, hepatic failure, and death during interferon alfa therapy. These individuals should not receive interferon alfa.b Discontinue the drug in patients who develop signs and symptoms of hepatic failure.b
Patients with chronic HBV infection and evidence of decreasing hepatic synthetic function (e.g., decreasing serum albumin concentrations, prolonged PT) may be at risk of clinical decompensation if an increase in ALT concentration occurs during interferon alfa therapy.b Closely monitor clinical symptoms and liver function if ALT increases occur.b
Potentially life-threatening pulmonary infiltrates, pneumonitis, and pneumonia have been reported in patients receiving systemic interferon alfa. Obtain a chest radiograph in any patient with fever, cough, dyspnea, or other respiratory symptoms. Closely monitor, or discontinue interferon alfa, in those with pulmonary infiltrates or impairment
Generic Name: ethinyl estradiol and desogestrel (EH thih nill ess tra DYE ole and des oh JESS trel)
Brand Names: Apri, Cesia, Cyclessa, Desogen, Kariva, Mircette, Ortho-Cept, Reclipsen, Solia, Velivet
Ethinyl estradiol and desogestrel contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Ethinyl estradiol and desogestrel are used as contraception to prevent pregnancy.
Ethinyl estradiol and desogestrel may also be used for other purposes not listed in this medication guide.
You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.
Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.
a history of a stroke or blood clot;
circulation problems (especially if caused by diabetes);
a hormone-related cancer such as breast or uterine cancer;
abnormal vaginal bleeding;
liver disease or liver cancer;
severe high blood pressure;
severe migraine headaches;
a heart valve disorder; or
a history of jaundice caused by birth control pills.
Before using this medication, tell your doctor if you have any of the following conditions. You may need a dosage adjustment or special tests to safely take birth control pills.
high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
high cholesterol or if you are overweight;
a history of depression;
gallbladder disease;
diabetes;
seizures or epilepsy;
a history of irregular menstrual cycles; or
a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.
Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).
You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.
The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.
Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.
If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.
Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.
Missing a pill increases your risk of becoming pregnant. Follow the directions on the patient information sheet provided with your medicine. If you do not have an information sheet, call your doctor for instructions if you miss a dose.
If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.
If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.
If you miss two "active" pills in a row in week 3, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.
If you miss three "active" tablets in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.
If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.
This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
a change in the pattern or severity of migraine headaches;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
swelling in your hands, ankles, or feet;
a breast lump; or
symptoms of depression (sleep problems, weakness, mood changes).
Less serious side effects may include:
mild nausea, vomiting, bloating, stomach cramps;
breast pain, tenderness, or swelling;
freckles or darkening of facial skin;
increased hair growth, loss of scalp hair;
changes in weight or appetite;
problems with contact lenses;
vaginal itching or discharge;
changes in your menstrual periods, decreased sex drive; or
headache, nervousness, dizziness, tired feeling.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Some drugs can make birth control pills less effective, which may result in pregnancy. Before using this medication, tell your doctor if you are using any of the following drugs:
acetaminophen (Tylenol) or ascorbic acid (vitamin C);
an antibiotic;
phenylbutazone (Azolid, Butazolidin);
St. John's wort;
seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), topiramate (Topamax), and others;
a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.
This list is not complete and there may be other drugs that can affect birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: Mircette side effects (in more detail)
