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TENEX
Overview
What is TENEX?
Tenex (guanfacine hydrochloride) is a centrally acting antihypertensive with α-adrenoceptor agonist properties in tablet form for oral administration.
The chemical name of Tenex (guanfacine hydrochloride) is N-amidino- 2-(2,6-dichlorophenyl) acetamide hydrochloride and its molecular weight is 282.56. Its structural formula is:
Guanfacine hydrochloride is a white to off-white powder; sparingly soluble in water and alcohol and slightly soluble in acetone. The tablets contain the following inactive ingredients:
1 mg—FD&C Red 40 aluminum lake, lactose, microcrystalline cellulose, povidone, stearic acid.
2 mg—D&C Yellow 10 aluminum lake, lactose, microcrystalline cellulose, povidone, stearic acid.
What does TENEX look like?
What are the available doses of TENEX?
Sorry No records found.
What should I talk to my health care provider before I take TENEX?
How should I use TENEX?
Tenex (guanfacine hydrochloride) is indicated in the
management of hypertension. Tenex may be given alone or in combination
with other antihypertensive agents, especially thiazide-type
diuretics.
The recommended initial dose of Tenex (guanfacine hydrochloride) when
given alone or in combination with another antihypertensive drug is 1 mg daily
given at bedtime to minimize somnolence. If after 3 to 4 weeks of therapy 1 mg
does not give a satisfactory result, a dose of 2 mg may be given, although most
of the effect of Tenex is seen at 1 mg (see ). Higher daily doses have been used, but
adverse reactions increase significantly with doses above 3 mg/day.
The frequency of rebound hypertension is low, but it can occur. When
rebound occurs, it does so after 2 - 4 days, which is delayed compared with
clonidine hydrochloride. This is consistent with the longer half-life of
guanfacine. In most cases, after abrupt withdrawal of guanfacine, blood
pressure returns to pretreatment levels slowly (within 2 - 4 days) without ill
effects.
What interacts with TENEX?
Tenex is contraindicated in patients with known hypersensitivity to guanfacine hydrochloride.
What are the warnings of TENEX?
Sorry No Records found
What are the precautions of TENEX?
Like other antihypertensive agents, Tenex (guanfacine hydrochloride)
should be used with caution in patients with severe coronary insufficiency,
recent myocardial infarction, cerebrovascular disease, or chronic renal or
hepatic failure.
Tenex, like other orally active central
α-adrenergic agonists, causes sedation or drowsiness,
especially when beginning therapy. These symptoms are dose-related (see
). When Tenex is
used with other centrally active depressants (such as phenothiazines,
barbiturates, or benzodiazepines), the potential for additive sedative effects
should be considered.
Abrupt cessation of therapy with orally active central
α-adrenergic agonists may be associated with increases
(from depressed on-therapy levels) in plasma and urinary catecholamines,
symptoms of "nervousness and anxiety" and, less commonly, increases in blood
pressure to levels significantly greater than those prior to
therapy.
What are the side effects of TENEX?
Adverse reactions noted with Tenex (guanfacine hydrochloride) are
similar to those of other drugs of the central
α-adrenoreceptor agonist class: dry mouth, sedation
(somnolence), weakness (asthenia), dizziness, constipation, and impotence.
While the reactions are common, most are mild and tend to disappear on
continued dosing.
Skin rash with exfoliation has been reported in a few cases; although
clear cause and effect relationships to Tenex could not be established, should
a rash occur, Tenex should be discontinued and the patient monitored
appropriately.
In the dose-response monotherapy study described under , the frequency of the
most commonly observed adverse reactions showed a dose relationship from 0.5 to
3 mg as follows:
The percent of patients who dropped out because of adverse reactions
are shown below for each dosage group.
The most common reasons for dropouts among patients who received
guanfacine were dry mouth, somnolence, dizziness, fatigue, weakness, and
constipation.
In the 12-week, placebo-controlled, dose-response study of guanfacine
administered with 25 mg chlorthalidone at bedtime, the frequency of the most
commonly observed adverse reactions showed a clear dose relationship from 0.5
to 3 mg as follows:
There were 41 premature terminations because of adverse reactions in
this study. The percent of patients who dropped out and the dose at which the
dropout occurred were as follows:
Reasons for dropouts among patients who received guanfacine were:
somnolence, headache, weakness, dry mouth, dizziness, impotence, insomnia,
constipation, syncope, urinary incontinence, conjunctivitis, paresthesia, and
dermatitis.
In a second 12-week placebo-controlled combination therapy study in
which the dose could be adjusted upward to 3 mg per day in 1-mg increments at
3-week intervals, i.e., a setting more similar to ordinary clinical use, the
most commonly recorded reactions were: dry mouth, 47%; constipation, 16%;
fatigue, 12%; somnolence, 10%; asthenia, 6%; dizziness, 6%; headache, 4%; and
insomnia, 4%.
Reasons for dropouts among patients who received guanfacine were:
somnolence, dry mouth, dizziness, impotence, constipation, confusion,
depression, and palpitations.
In the clonidine/guanfacine comparison described in , the most common adverse
reactions noted were as follows:
Adverse reactions occurring in 3% or less of patients in the three
controlled trials of Tenex (guanfacine hydrochloride) with a diuretic were:
Cardiovascular- bradycardia, palpitations, substernal pain
Gastrointestinal- abdominal pain, diarrhea, dyspepsia, dysphagia,
nausea
CNS- amnesia, confusion, depression, insomnia, libido decrease
ENT disorders- rhinitis, taste perversion, tinnitus
Eye disorders- conjunctivitis, iritis, vision disturbance
Musculoskeletal- leg cramps, hypokinesia
Respiratory- dyspnea
Dermatologic- dermatitis, pruritus, purpura, sweating
Urogenital- testicular disorder, urinary incontinence
Other- malaise, paresthesia, paresis
Adverse reaction reports tend to decrease over time. In an open-label
trial of one year's duration, 580 hypertensive subjects were given guanfacine,
titrated to achieve goal blood pressure, alone (51%), with diuretic (38%), with
beta blocker (3%), with diuretic plus beta blocker (6%), or with diuretic plus
vasodilator (2%). The mean daily dose of guanfacine reached was 4.7 mg.
There were 52 (8.9%) dropouts due to adverse effects in this 1-year
trial. The causes were: dry mouth (n = 20), weakness (n = 12), constipation (n
= 7), somnolence (n = 3), nausea (n = 3), orthostatic hypotension (n = 2),
insomnia (n = 1), rash (n = 1), nightmares (n = 1), headache (n = 1), and
depression (n = 1).
An open-label postmarketing study involving 21,718 patients was
conducted to assess the safety of Tenex (guanfacine hydrochloride) 1 mg/day
given at bedtime for 28 days. Tenex was administered with or without other
antihypertensive agents. Adverse events reported in the postmarketing study at
an incidence greater than 1% included dry mouth, dizziness, somnolence,
fatigue, headache and nausea. The most commonly reported adverse events in this
study were the same as those observed in controlled clinical trials.
Less frequent, possibly Tenex-related events observed in the
postmarketing study and/or reported spontaneously include:
BODY AS A WHOLE asthenia, chest pain, edema, malaise, tremor
CARDIOVASCULAR bradycardia, palpitations, syncope, tachycardia
CENTRAL NERVOUS SYSTEM paresthesias, vertigo
EYE DISORDERS blurred vision
GASTROINTESTINAL SYSTEM abdominal pain, constipation, diarrhea,
dyspepsia
LIVER AND BILLIARY SYSTEM abnormal liver function tests
MUSCULO-SKELETAL SYSTEM arthralgia, leg cramps, leg pain, myalgia
PSYCHIATRIC agitation, anxiety, confusion, depression, insomnia,
nervousness
RREPRODUCTIVE SYSTEM, Male- impotence
RESPIRATORY SYSTEM dyspnea
SKIN AND APPENDAGES alopecia, dermatitis, exfoliative dermatitis,
pruritus, rash
SPECIAL SENSES alterations in taste
URINARY SYSTEM nocturia, urinary frequency
Rare, serious disorders with no definitive cause and effect
relationship to Tenex have been reported spontaneously and/or in the
postmarketing study. These events include acute renal failure, cardiac
fibrillation, cerebrovascular accident, congestive heart failure, heart block,
and myocardial infarction.
| AdverseReaction | Placebon=59 | 0.5 mgn=60 | 1 mgn=61 | 2 mgn=60 | 3 mgn=59 |
|---|---|---|---|---|---|
| Dry Mouth | 0% | 10% | 10% | 42% | 54% |
| Somnolence | 8% | 5% | 10% | 13% | 39% |
| Asthenia | 0% | 2% | 3% | 7% | 3% |
| Dizziness | 8% | 12% | 2% | 8% | 15% |
| Headache | 8% | 13% | 7% | 5% | 3% |
| Impotence | 0% | 0% | 0% | 7% | 3% |
| Constipation | 0% | 2% | 0% | 5% | 15% |
| Fatigue | 2% | 2% | 5% | 8% | 10% | Placebo | 0.5 mg | 1 mg | 2 mg | 3 mg |
| Percent dropouts | 0% | 2.0% | 5.0% | 13% | 32% | AdverseReaction | Placebon=73 | 0.5 mgn=72 | 1 mgn=72 | 2 mgn=72 | 3 mgn=72 |
| Dry Mouth | 5 (7%) | 4 (5%) | 6 (8%) | 8 (11%) | 20 (28%) |
| Somnolence | 1 (1%) | 3 (4%) | 0 (0%) | 1 (1%) | 10 (14%) |
| Asthenia | 0 (0%) | 2 (3%) | 0 (0%) | 2 (2%) | 7 (10%) |
| Dizziness | 2 (2%) | 1 (1%) | 3 (4%) | 6 (8%) | 3 (4%) |
| Headache | 3 (4%) | 4 (3%) | 3 (4%) | 1 (1%) | 2 (2%) |
| Impotence | 1 (1%) | 1 (0%) | 0 (0%) | 1 (1%) | 3 (4%) |
| Constipation | 0 (0%) | 0 (0%) | 0 (0%) | 1 (1%) | 1 (1%) |
| Fatigue | 3 (3%) | 2 (3%) | 2 (3%) | 5 (6%) | 3 (4%) | Dose | Placebo | 0.5 mg | 1 mg | 2 mg | 3 mg |
| Percent dropouts | 6.9% | 4.2% | 3.2% | 6.9% | 8.3% | AdverseReactions | Guanfacine(n=279) | Clonidine(n=278) |
| Dry Mouth | 30% | 37% | |||
| Somnolence | 21% | 35% | |||
| Dizziness | 11% | 8% | |||
| Constipation | 10% | 5% | |||
| Fatigue | 9% | 8% | |||
| Headache | 4% | 4% | |||
| Insomnia | 4% | 3% | |||
| AdverseReaction | Incidence of adverse reactions at any time during the study | Incidence of adverse reactions at end of one year | |||
| n = 580 | n = 580 | ||||
| Dry Mouth | 60% | 15% | |||
| Drowsiness | 33% | 6% | |||
| Dizziness | 15% | 1% | |||
| Constipation | 14% | 3% | |||
| Weakness | 5% | 1% | |||
| Headache | 4% | 0.2% | |||
| Insomnia | 5% | 0% |
What should I look out for while using TENEX?
Tenex is contraindicated in patients with known hypersensitivity to
guanfacine hydrochloride.
What might happen if I take too much TENEX?
Drowsiness, lethargy, bradycardia and hypotension have been observed
following overdose with guanfacine.
A 25-year-old female intentionally ingested 60 mg. She presented with
severe drowsiness and bradycardia of 45 beats/minute. Gastric lavage was
performed and an infusion of isoproterenol (0.8 mg in 12 hours) was
administered. She recovered quickly and without sequelae.
A 28-year-old female who ingested 30 - 40 mg developed only lethargy,
was treated with activated charcoal and a cathartic, was monitored for 24
hours, and was discharged in good health.
A 2-year-old male weighing 12 kg who ingested up to 4 mg of guanfacine
developed lethargy. Gastric lavage (followed by activated charcoal and sorbitol
slurry via NG tube) removed some tablet fragments within 2 hours after
ingestion, and vital signs were normal.
During 24-hour observation in ICU, systolic pressure was 58 and heart
rate 70 at 16 hours post-ingestion. No intervention was required, and child
was discharged fully recovered the next day.
Gastric lavage and supportive therapy as appropriate.
Guanfacine is not dialyzable in clinically significant amounts
(2.4%).
How should I store and handle TENEX?
Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. NovoLog should not be drawn into a syringe and stored for later use.Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light. Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.The storage conditions are summarized in the following table:NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.Infusion bags prepared as indicated under are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag. Tenex (guanfacine hydrochloride) Tablets are available in the following dosing strengths (expressed in equivalent amounts of guanfacine): 1 mg—light pink, diamond-shaped tablet embossed with a 1 and engraved RP on one side and engraved TENEX on the other side in bottles of 100 (NDC 67857-705-01) and 500 (NDC 67857-705-05). 2 mg—yellow, diamond-shaped tablet, one side engraved TENEX, other side engraved 2 with RP below it in bottles of 100 (NDC 67857-706-01). Store at controlled temperature, between 20ଌ and 25°C (68°F and 77°F).Dispense in a tight, light-resistant container.Distributed by:Promius Pharma, LLCBridgewater, NJ 08807Manufactured by:PATHEON, Puerto Rico, Inc.Manati, Puerto Rico 00674, USARevised: May 2013 Tenex (guanfacine hydrochloride) Tablets are available in the following dosing strengths (expressed in equivalent amounts of guanfacine): 1 mg—light pink, diamond-shaped tablet embossed with a 1 and engraved RP on one side and engraved TENEX on the other side in bottles of 100 (NDC 67857-705-01) and 500 (NDC 67857-705-05). 2 mg—yellow, diamond-shaped tablet, one side engraved TENEX, other side engraved 2 with RP below it in bottles of 100 (NDC 67857-706-01). Store at controlled temperature, between 20ଌ and 25°C (68°F and 77°F).Dispense in a tight, light-resistant container.Distributed by:Promius Pharma, LLCBridgewater, NJ 08807Manufactured by:PATHEON, Puerto Rico, Inc.Manati, Puerto Rico 00674, USARevised: May 2013 Tenex (guanfacine hydrochloride) Tablets are available in the following dosing strengths (expressed in equivalent amounts of guanfacine): 1 mg—light pink, diamond-shaped tablet embossed with a 1 and engraved RP on one side and engraved TENEX on the other side in bottles of 100 (NDC 67857-705-01) and 500 (NDC 67857-705-05). 2 mg—yellow, diamond-shaped tablet, one side engraved TENEX, other side engraved 2 with RP below it in bottles of 100 (NDC 67857-706-01). Store at controlled temperature, between 20ଌ and 25°C (68°F and 77°F).Dispense in a tight, light-resistant container.Distributed by:Promius Pharma, LLCBridgewater, NJ 08807Manufactured by:PATHEON, Puerto Rico, Inc.Manati, Puerto Rico 00674, USARevised: May 2013 Tenex (guanfacine hydrochloride) Tablets are available in the following dosing strengths (expressed in equivalent amounts of guanfacine): 1 mg—light pink, diamond-shaped tablet embossed with a 1 and engraved RP on one side and engraved TENEX on the other side in bottles of 100 (NDC 67857-705-01) and 500 (NDC 67857-705-05). 2 mg—yellow, diamond-shaped tablet, one side engraved TENEX, other side engraved 2 with RP below it in bottles of 100 (NDC 67857-706-01). Store at controlled temperature, between 20ଌ and 25°C (68°F and 77°F).Dispense in a tight, light-resistant container.Distributed by:Promius Pharma, LLCBridgewater, NJ 08807Manufactured by:PATHEON, Puerto Rico, Inc.Manati, Puerto Rico 00674, USARevised: May 2013 Tenex (guanfacine hydrochloride) Tablets are available in the following dosing strengths (expressed in equivalent amounts of guanfacine): 1 mg—light pink, diamond-shaped tablet embossed with a 1 and engraved RP on one side and engraved TENEX on the other side in bottles of 100 (NDC 67857-705-01) and 500 (NDC 67857-705-05). 2 mg—yellow, diamond-shaped tablet, one side engraved TENEX, other side engraved 2 with RP below it in bottles of 100 (NDC 67857-706-01). Store at controlled temperature, between 20ଌ and 25°C (68°F and 77°F).Dispense in a tight, light-resistant container.Distributed by:Promius Pharma, LLCBridgewater, NJ 08807Manufactured by:PATHEON, Puerto Rico, Inc.Manati, Puerto Rico 00674, USARevised: May 2013 Tenex (guanfacine hydrochloride) Tablets are available in the following dosing strengths (expressed in equivalent amounts of guanfacine): 1 mg—light pink, diamond-shaped tablet embossed with a 1 and engraved RP on one side and engraved TENEX on the other side in bottles of 100 (NDC 67857-705-01) and 500 (NDC 67857-705-05). 2 mg—yellow, diamond-shaped tablet, one side engraved TENEX, other side engraved 2 with RP below it in bottles of 100 (NDC 67857-706-01). Store at controlled temperature, between 20ଌ and 25°C (68°F and 77°F).Dispense in a tight, light-resistant container.Distributed by:Promius Pharma, LLCBridgewater, NJ 08807Manufactured by:PATHEON, Puerto Rico, Inc.Manati, Puerto Rico 00674, USARevised: May 2013 Tenex (guanfacine hydrochloride) Tablets are available in the following dosing strengths (expressed in equivalent amounts of guanfacine): 1 mg—light pink, diamond-shaped tablet embossed with a 1 and engraved RP on one side and engraved TENEX on the other side in bottles of 100 (NDC 67857-705-01) and 500 (NDC 67857-705-05). 2 mg—yellow, diamond-shaped tablet, one side engraved TENEX, other side engraved 2 with RP below it in bottles of 100 (NDC 67857-706-01). Store at controlled temperature, between 20ଌ and 25°C (68°F and 77°F).Dispense in a tight, light-resistant container.Distributed by:Promius Pharma, LLCBridgewater, NJ 08807Manufactured by:PATHEON, Puerto Rico, Inc.Manati, Puerto Rico 00674, USARevised: May 2013 Tenex (guanfacine hydrochloride) Tablets are available in the following dosing strengths (expressed in equivalent amounts of guanfacine): 1 mg—light pink, diamond-shaped tablet embossed with a 1 and engraved RP on one side and engraved TENEX on the other side in bottles of 100 (NDC 67857-705-01) and 500 (NDC 67857-705-05). 2 mg—yellow, diamond-shaped tablet, one side engraved TENEX, other side engraved 2 with RP below it in bottles of 100 (NDC 67857-706-01). Store at controlled temperature, between 20ଌ and 25°C (68°F and 77°F).Dispense in a tight, light-resistant container.Distributed by:Promius Pharma, LLCBridgewater, NJ 08807Manufactured by:PATHEON, Puerto Rico, Inc.Manati, Puerto Rico 00674, USARevised: May 2013
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Hemodynamic studies in man showed that the decrease in blood
pressure observed after single-dose or long-term oral treatment with
guanfacine was accompanied by a significant decrease in peripheral
resistance and a slight reduction in heart rate (5 beats/min). Cardiac
output under conditions of rest or exercise was not altered by
guanfacine.
Tenex (guanfacine hydrochloride) lowered elevated plasma renin
activity and plasma catecholamine levels in hypertensive patients, but
this does not correlate with individual blood-pressure responses.
Growth hormone secretion was stimulated with single oral doses of
2 and 4 mg of guanfacine. Long-term use of Tenex had no effect on
growth hormone levels.
Guanfacine had no effect on plasma aldosterone. A slight but
insignificant decrease in plasma volume occurred after one month of
guanfacine therapy. There were no changes in mean body weight or
electrolytes.
Non-Clinical Toxicology
Tenex is contraindicated in patients with known hypersensitivity to guanfacine hydrochloride.In vitro
Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly coadministered antiepileptic drugs.
The drug interaction data described in this section were obtained from studies involving healthy adults and adult patients with epilepsy.
Like other antihypertensive agents, Tenex (guanfacine hydrochloride) should be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease, or chronic renal or hepatic failure.
Tenex, like other orally active central α-adrenergic agonists, causes sedation or drowsiness, especially when beginning therapy. These symptoms are dose-related (see ). When Tenex is used with other centrally active depressants (such as phenothiazines, barbiturates, or benzodiazepines), the potential for additive sedative effects should be considered.
Abrupt cessation of therapy with orally active central α-adrenergic agonists may be associated with increases (from depressed on-therapy levels) in plasma and urinary catecholamines, symptoms of "nervousness and anxiety" and, less commonly, increases in blood pressure to levels significantly greater than those prior to therapy.
Adverse reactions noted with Tenex (guanfacine hydrochloride) are similar to those of other drugs of the central α-adrenoreceptor agonist class: dry mouth, sedation (somnolence), weakness (asthenia), dizziness, constipation, and impotence. While the reactions are common, most are mild and tend to disappear on continued dosing.
Skin rash with exfoliation has been reported in a few cases; although clear cause and effect relationships to Tenex could not be established, should a rash occur, Tenex should be discontinued and the patient monitored appropriately.
In the dose-response monotherapy study described under , the frequency of the most commonly observed adverse reactions showed a dose relationship from 0.5 to 3 mg as follows:
The percent of patients who dropped out because of adverse reactions are shown below for each dosage group.
The most common reasons for dropouts among patients who received guanfacine were dry mouth, somnolence, dizziness, fatigue, weakness, and constipation.
In the 12-week, placebo-controlled, dose-response study of guanfacine administered with 25 mg chlorthalidone at bedtime, the frequency of the most commonly observed adverse reactions showed a clear dose relationship from 0.5 to 3 mg as follows:
There were 41 premature terminations because of adverse reactions in this study. The percent of patients who dropped out and the dose at which the dropout occurred were as follows:
Reasons for dropouts among patients who received guanfacine were: somnolence, headache, weakness, dry mouth, dizziness, impotence, insomnia, constipation, syncope, urinary incontinence, conjunctivitis, paresthesia, and dermatitis.
In a second 12-week placebo-controlled combination therapy study in which the dose could be adjusted upward to 3 mg per day in 1-mg increments at 3-week intervals, i.e., a setting more similar to ordinary clinical use, the most commonly recorded reactions were: dry mouth, 47%; constipation, 16%; fatigue, 12%; somnolence, 10%; asthenia, 6%; dizziness, 6%; headache, 4%; and insomnia, 4%.
Reasons for dropouts among patients who received guanfacine were: somnolence, dry mouth, dizziness, impotence, constipation, confusion, depression, and palpitations.
In the clonidine/guanfacine comparison described in , the most common adverse reactions noted were as follows:
Adverse reactions occurring in 3% or less of patients in the three controlled trials of Tenex (guanfacine hydrochloride) with a diuretic were:
Cardiovascular- bradycardia, palpitations, substernal pain
Gastrointestinal- abdominal pain, diarrhea, dyspepsia, dysphagia, nausea
CNS- amnesia, confusion, depression, insomnia, libido decrease
ENT disorders- rhinitis, taste perversion, tinnitus
Eye disorders- conjunctivitis, iritis, vision disturbance
Musculoskeletal- leg cramps, hypokinesia
Respiratory- dyspnea
Dermatologic- dermatitis, pruritus, purpura, sweating
Urogenital- testicular disorder, urinary incontinence
Other- malaise, paresthesia, paresis
Adverse reaction reports tend to decrease over time. In an open-label trial of one year's duration, 580 hypertensive subjects were given guanfacine, titrated to achieve goal blood pressure, alone (51%), with diuretic (38%), with beta blocker (3%), with diuretic plus beta blocker (6%), or with diuretic plus vasodilator (2%). The mean daily dose of guanfacine reached was 4.7 mg.
There were 52 (8.9%) dropouts due to adverse effects in this 1-year trial. The causes were: dry mouth (n = 20), weakness (n = 12), constipation (n = 7), somnolence (n = 3), nausea (n = 3), orthostatic hypotension (n = 2), insomnia (n = 1), rash (n = 1), nightmares (n = 1), headache (n = 1), and depression (n = 1).
An open-label postmarketing study involving 21,718 patients was conducted to assess the safety of Tenex (guanfacine hydrochloride) 1 mg/day given at bedtime for 28 days. Tenex was administered with or without other antihypertensive agents. Adverse events reported in the postmarketing study at an incidence greater than 1% included dry mouth, dizziness, somnolence, fatigue, headache and nausea. The most commonly reported adverse events in this study were the same as those observed in controlled clinical trials.
Less frequent, possibly Tenex-related events observed in the postmarketing study and/or reported spontaneously include:
BODY AS A WHOLE asthenia, chest pain, edema, malaise, tremor
CARDIOVASCULAR bradycardia, palpitations, syncope, tachycardia
CENTRAL NERVOUS SYSTEM paresthesias, vertigo
EYE DISORDERS blurred vision
GASTROINTESTINAL SYSTEM abdominal pain, constipation, diarrhea, dyspepsia
LIVER AND BILLIARY SYSTEM abnormal liver function tests
MUSCULO-SKELETAL SYSTEM arthralgia, leg cramps, leg pain, myalgia
PSYCHIATRIC agitation, anxiety, confusion, depression, insomnia, nervousness
RREPRODUCTIVE SYSTEM, Male- impotence
RESPIRATORY SYSTEM dyspnea
SKIN AND APPENDAGES alopecia, dermatitis, exfoliative dermatitis, pruritus, rash
SPECIAL SENSES alterations in taste
URINARY SYSTEM nocturia, urinary frequency
Rare, serious disorders with no definitive cause and effect relationship to Tenex have been reported spontaneously and/or in the postmarketing study. These events include acute renal failure, cardiac fibrillation, cerebrovascular accident, congestive heart failure, heart block, and myocardial infarction.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).