LIDOCAINE HCl Injection, USP
IV for Cardiac Arrhythmias
[September 13, 1996: Fujisawa]
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PRECAUTIONS:
-
General: In second paragraph, the words "e.g., by isoproterenol or by electric pacing"
have been deleted.
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Drug Interactions: Third paragraph has been added that states serum concentrations
of Lidocaine HCl Injection may become excessive during concomitant beta-blocker
administration.
- Carcinogenesis, Mutagenesis, Impairment of Fertility: Revised to indicate that animal
studies of Lidocaine HCl Injection to evaluate carcinogenic and mutagenic potential or
effect on fertility have not been concluded (versus "conducted", as previously).
-
ADVERSE REACTIONS:
-
Central Nervous System: Respirator has been changed to respiratory depression.
- Cardiovascular System: Second sentence has been added, which states that
continuous monitoring of blood pressure and electrocardiogram are essential to prevent the listed
adverse events.
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LUPRON DEPOT
(leuprolide acetate)
[September 12, 1996: TAP Holdings]
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ADVERSE REACTIONS:
-
Section revised to include reports from post-marketing surveillance and information
regarding bone mineral density:
Mood swings, including depression, have been reported as physiologic effect of decreased
sex steroids. There have been very rare reports of suicidal ideation and attempt, with many,
but not all, of these patients having a history of depression or other psychiatric illness. Patients
should be counseled on the possibility of worsening of depression.
There have been rare reports of symptoms consistent with anaphylactoid or asthmatic
process, with rash, urticaria and photosensitivity reactions also reported.
Localized reactions, including induration and abscess at the site of injection, have been
reported.
- Cardiovascular System: hypotension;
- Hemic and Lymphatic System: decreased WBC;
- Central/Peripheral Nervous System: peripheral neuropathy, spinal
fracture/paralysis;
- Musculoskeletal System: tenosynovitis-like symptoms;
- Urogenital System: prostate pain.
See other Lupron Depot and Lupron Injection package inserts for other events reported in
different patient populations.
- Endometriosis: Subsection revised to indicate that in controlled study in
endometriosis patients,
patients tested at six or twelve months after discontinuation of therapy showed mean bone
density return to within 2% of pretreatment.
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MAXAQUIN
(lomefloxacin HCl)
[September 11, 1996: G.D. Searle]
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WARNINGS:
-
A new paragraph has been added that indicates the reporting of ruptures of the shoulder,
hand and Achilles tendons that required surgical repair or resulted in prolonged disability with
lomefloxacin. Lomefloxacin should be discontinued if pain, inflammation or tendon rupture is
experienced by the patient, who should rest and refrain from exercise until the diagnosis of
tendonitis or tendon rupture has been confidently excluded. Tendon rupture can occur at any time
during or after therapy with lomefloxacin.
-
PRECAUTIONS:
-
Information for Patients: Revised to include a new statement that indicates patients
should be advised that lomefloxacin treatment is to be discontinued and their physician informed if
they experience pain, inflammation or tendon rupture, and to rest and refrain from exercise until
the diagnosis of tendonitis or tendon rupture has been confidently excluded.
[September 27, 1996: G.D. Searle]
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PRECAUTIONS:
-
Information for Patients: Revised to further specify that the risk of developing
photosensitivity from sunlight may be reduced by taking the lomefloxacin daily dose at least 12
hours before exposure to the sun (e.g., in the evening).
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MAXIDEX
(dexamethasone)
0.1% Ophthalmic Suspension
[September 26, 1996: Alcon]
PRECAUTIONS:-
Nursing Mothers: Revised to indicate that systemically administered corticosteroids
appear in human milk and could suppress growth, interfere with endogenous corticosteroid
production, or cause other untoward effects. It is not known whether topical administration of
corticosteroids could result in sufficient systemic absorption to produce detectable quantities in
human milk. Because many drugs are excreted in human milk, caution should be exercised when
Maxidex Ophthalmic Suspension is administered to a nursing woman.
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NOROXIN
(norfloxacin)
[September 12, 1996: Merck]
- WARNINGS:
-
A new paragraph has been added that indicates the reporting of ruptures of the shoulder,
hand and Achilles tendons that required surgical repair or resulted in prolonged disability with
norfloxacin. Norfloxacin should be discontinued if pain, inflammation or tendon rupture is
experienced by the patient, who should rest and refrain from exercise until the diagnosis of
tendonitis or tendon rupture has been confidently excluded. Tendon rupture can occur at any time
during or after therapy with norfloxacin.
-
PRECAUTIONS:
-
Information for Patients: A new statement has been added that indicates patients
should be advised that norfloxacin treatment is to be discontinued and their physician informed if
they experience pain, inflammation or tendon rupture, and to rest and refrain from exercise until
the diagnosis of tendonitis or tendon rupture has been confidently excluded.
-
ADVERSE REACTIONS:
-
Musculoskeletal: Tendon rupture added to list of adverse reactions.
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NORVIR
(ritonavir)
[September 24, 1996: Abbott]
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BOXED WARNING:
-
Revised with addition of ergot alkaloid preparations to list of drugs that when
co-administered with Norvir may result in potentially serious and/or life-threatening adverse
events due to possible effects of Norvir on the hepatic metabolism of certain drugs.
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CONTRAINDICATIONS:
-
Revised with addition of dihydroergotamine, ergotamine and pimozide to list of drugs in
which ritonavir is expected to produce large increases in plasma concentrations.
Revised with addition of notation that post-marketing reports of co-administration of
ritonavir with ergotamine or dihydroergotamine have been associated with acute ergot
toxicity characterized by peripheral vasospasm and ischemia of the extremities; thus, these
drugs should not be
co-administered with ritonavir.
Revised to indicate that co-administration of ritonavir with specified highly
metabolized sedatives and hypnotics is expected (revised from "likely") to produce large increases in
these agents, with caution against co-administeration with ritonavir as before.
-
WARNINGS:
-
Allergic reactions including urticaria, mild skin eruptions, bronchospasm and angioedema
have been reported, as have rare cases of anaphylaxis and Stevens-Johnson syndrome.
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PRECAUTIONS:
-
Hemophilia: There have been reports of increased bleeding, including spontaneous
skin hemotomas and hemoarthrosis, in patients with hemophilia type A and B treated with
protease inhibitors, with some patients being given additional factor VIII. In more than half of the
reported cases, protease inhibitor treatment was continued or reintroduced; a causal relationship
has not been established.
-
Laboratory Tests: Cholesterol added to list of laboratory tests with which ritonavir
has been associated with alterations.
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DRUG INTERACTIONS:
-
Effects on ritonavir: Agents which increase CYP3A activity are (revised from "would
be") expected to increase ritonavir clearance.
-
Effects on co-administered drugs: Numerous revisions made to this subsection, as
clinical drug interaction studies with ritonavir and some commonly administered drugs have been
conducted. Drugs that may need dose adjustment based on information from these studies are
listed in this subsection in alphabetical order, with didanosine added and saquinavar information
revised [see complete subsection in package insert].
- In addition, Table 3 summarizes some commonly administered drugs,
categorized by the predicted magnitude of interaction that could result if co-administered with
ritonavir [see complete subsection in package insert].
-
Post-Marketing Experience with Drugs Listed in Table 3: Cardiac and neurologic
events have been reported when ritonavir has been co-administered with disopyramide,
mexiletine, nefazodone or fluoxetine; the possibility of drug interaction cannot be excluded.
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ADVERSE REACTIONS:
-
Post-Marketing Experience: There have been postmarketing reports of seizure, and
hyperglycemia in individuals with/without known diabetes history has been reported; a cause
and effect relationship has not been established. Dehydration, usually associated with
gastrointestinal symptoms and sometimes resulting in hypotension, syncope or renal insufficiency,
has been reported, while syncope, orthostatic hypotension and renal insufficiency without known
dehydration have also been reported.
-
OVERDOSAGE:
-
Revised to indicate that a postmarketing case of renal failure with eosinophilia has been
reported with ritonavir overdose.
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DOSAGE AND ADMINISTRATION:
-
Revised to indicate that dose titration may help to reduce treatment-emergent adverse
events while maintaining appropriate ritonavir plasma levels, and that patients should be aware
that frequently observed adverse events, such as mild to moderate gatrointestinal disturbances and
parathesias, may diminish as therapy is continued.
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PRIMAXIN
I.V. (imipenem/cilastatin sodium)
[September 12, 1996: Merck]
-
ADVERSE REACTIONS:
-
Granulocytic Patients: Subsection has been removed.
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PRINIVIL
(lisinopril)
[September 3, 1996: Merck]
-
WARNINGS:
-
Fetal/Neonatal Morbidity and Mortality: Revised to present data from studies of
pregnant mice, rats and rabbits (in which no teratogenic effects were seen) in terms of maximum
recommended human daily dose (MRHDD) on a body surface area basis, rather than the
previously utilized mg/kg/day [see complete subsection in package insert].
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PRECAUTIONS:
-
Carcinogenesis, Mutagenesis, Impairment of Fertility: As with WARNINGS, revised
to present data from rodent studies in terms of MRHDD on a body surface area, rather than
mg/kg/day, basis [see complete subsection in package insert].
-
Nursing Mothers: Revised to indicate that given the potential for serious adverse
events in nursing infants from ACE inhibitors, it should be decided whether to discontinue
Prinivil, taking into account the importance of the drug to the mother.
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OVERDOSAGE:
-
Revised to indicate that no rats, and 1 of 20 mice, died after receiving a single oral dose of
20 g/kg.
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PRINZIDE
(lisinopril/hydrochlorothiazide)
[September 3, 1996: Merck]
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WARNINGS:
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Pregnancy, Lisinopril-Hydrochlorothiazide: Revised to present data from studies of
pregnant mice and rats in terms of maximum recommended human daily dose (MRHDD) on a
body surface area basis, rather than the previously utilized mg/kg/day [see complete subsection in
package insert].
- Lisinopril, Fetal/Neonatal Morbidity and Mortality: Revised to present data
from studies of pregnant mice, rats and rabbits (in which no teratogenic effects were seen) in
terms of maximum recommended human daily dose (MRHDD) on a body surface area basis,
rather than the previously utilized mg/kg/day [see complete subsection in package insert].
- Hydrochlorothiazide: This entire subsection has been revised: Oral
administration to pregnant mice (doses up to 3000 mg/kg/day) and rats (doses up to 1000
mg/kg/day) during their respective periods of major organogenesis produced no evidence of fetal
harm, with these doses > 150 times MRHDD on a body surface area basis. Thiazides cross the
placental barrier and appear in cord blood, with a risk of fetal or neonatal jaundice,
thrombocytopenia and possibly other adverse reactions that have occurred in adults.
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PRECAUTIONS:
-
Carcinogenesis, Mutagenesis, Impairment of Fertility, Lisinopril: Revised to present
data from rodent studies in terms of MRHDD on a body surface area, rather than mg/kg/day,
basis [see complete subsection in package insert].
- Carcinogenesis, Mutagenesis, Impairment of Fertility, Hydrochlorothiazide:
Revised to present data from rodent studies in terms of MRHDD on a body surface area, rather
than mg/kg/day, basis [see complete subsection in package insert].
- Nursing Mothers: Revised to indicate that given the potential for serious
adverse events in nursing infants from ACE inhibitors and hydrochlorothiazide, it should be
decided whether to discontinue Prinzide, taking into account the importance of the drug to the
mother.
-
OVERDOSAGE:
-
Lisinopril: Revised to indicate that no rats, and 1 of 20 mice, died after receiving a
single oral dose of 20 g/kg.
- Hydrochlorothiazide: Revised to indicate that no rats or mice died after
receiving a single oral dose of 10 g/kg.
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SALAGEN
(pilocarpine HCl)
[September 27, 1996: MGI Pharma]
-
WARNINGS:
-
Ocular: First paragraph of this subsection (which began "Careful examination of the
fundus" and ended "this finding is not known") is deleted in its entirety. The revised Ocular
subsection is now comprised by the original second paragraph (which begins "Ocular formulations
of pilocarpine" and ends "performing hazardous activities in reduced lighting") [see complete
subsection in package insert].
- Cardiovascular Disease: Revised by replacing phrase "cardiovascular disease"
with significant cardiovascular disease in the last sentence.
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TAMBOCOR
(flecainide acetate)
[September 20, 1996: 3M]
-
WARNINGS:
-
Subsection that incorporates results of the Cardiac Arrhythmia Suppression Trial (CAST)
results revised to note that while applicability of these results to other populations (e.g., those
without recent myocardial infarction) is uncertain, at present it is prudent to consider the risks of
using Class 1c agents (including Tambocor), coupled with lack of evidence of improved survival,
generally unacceptable in patients without life-threatening ventricular arrhythmias, even if they are
experiencing unpleasant, but not life-threatening, symptoms or signs.
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TOBRADEX
(tobramycin/dexamethasone)
Ophthalmic Ointment
[September 26, 1996: Alcon]
-
PRECAUTIONS:
-
Nursing Mothers: Revised to indicate that systemically administered corticosteroids
appear in human milk and could suppress growth, interfere with endogenous corticosteroid
production, or cause other untoward effects. It is not known whether topical administration of
corticosteroids could result in sufficient systemic absorption to produce detectable quantities in
human milk. Because many drugs are excreted in human milk, caution should be exercised when
Tobradex Ophthalmic Ointment is administered to a nursing woman.
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ZINACEF
(cefuroxime sodium)
[September 11, 1996: Glaxo Wellcome]
-
WARNINGS:
-
Pseudomembraneous colitis statements contained in the section revised, with the notation
regarding in vitro binding of toxin to cholestyramine and colestipol resins removed. In addition,
statements were revised to indicate that when the diagnosis of pseudomembraneous colitis has
been made, appropriate therapeutic measures should be initiated. Mild cases are usually
responsive to drug discontinuation alone, while in moderate to severe cases consideration should
be given to management with fluids and electrolytes, protein supplementation, and treatment with
an antibacterial drug clinically effective against Clostridium difficile colitis. The recommendations
for treatment when the colitis is not relieved by drug discontinuation or is severe remain as before.
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